The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

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1 The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall potential risks or benefits of a product which are based on an evaluation of an entire research program. Before prescribing any Takeda products, healthcare professionals should consult prescribing information for the product approved in their country.

2 Page 3 of SYNOPSIS Name of Sponsor: Takeda Pharmaceuticals North America, Inc. Name of Finished Product: Ramelteon (TAK-375) Investigator: Suzanne K Swan, MD Publication: None Study Period: 26 February 2003 to 29 August 2003 OBJECTIVES Study Center: DaVita Clinical Research 825 South Eighth Street, Suite 300 Minneapolis, MN Phase of Development: Phase I Primary: The primary objective of this study was to evaluate the pharmacokinetic profile of single and multiple oral doses of ramelteon in subjects with varying degrees of renal impairment. Secondary: The secondary objectives of this study were to evaluate the safety and tolerability of single and multiple oral doses of ramelteon in subjects with varying degrees of renal impairment; to measure hemodialysis clearance of ramelteon; and to evaluate serum concentrations of ramelteon in subjects on hemodialysis. METHODOLOGY This was an open-label, single- and multiple-dose, pharmacokinetic study with a single treatment sequence. A schematic of the study design follows: Treatment Period Screening Baseline Single Ramelteon Dose Washout Multiple Ramelteon Doses Post Dosing Discharge Days -28 to -2 Day 1 Day 1 Days 2 to 3 Days 4 to 8 Day 9 Day 10 Subjects were stratified into groups based on creatinine clearance (CLCr) levels as presented below.

3 Page 4 of 4601 Matched Group Renal Function (a) Group Renal Function (a) B Mildly Impaired (CLCr 50-80) A1 (CLCr > 80) Matched to Mildly Impaired C Moderately Impaired (CLCr 30-49) A2 (CLCr > 80) Matched to Moderately Impaired D Severely Impaired (CLCr 30) A3 (CLCr > 80) Matched to Severely Impaired E Hemodialysis (No or Negligible Urine Output) (a) CLCr measured in units of ml/min/1.73m 2 A4 (CLCr > 80) Matched to Hemodialysis Number of Subjects (Planned and Analyzed): Planned: 64 subjects Analyzed: Pharmacokinetics 50 subjects for Day 1 and 49 subjects for Day 8; Safety 50 subjects Diagnosis and Main Criteria for Inclusion: To qualify for study participation, subjects must have had/been: men or nonpregnant, nonlactating women; 18 to 79 years of age, inclusive; at least 50 kg (110 pounds) with a body mass index less than or equal to 40 kg/m 2 ; able to comprehend and willing to sign an informed consent form; negative test results for selected substances of abuse; negative hepatitis panel test results at Screening (or hepatitis B vaccination if positive for hepatitis B surface antibody); negative human immunodeficiency virus antibody test results at Screening; no clinically important abnormal finding other than related to chronic renal insufficiency and diabetes as determined by the investigator via medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests (renally impaired subjects) or clinical laboratory results within the reference ranges or that were acceptable to the investigator or sponsor and deemed in good health as determined by the investigator (ie, via medical history and physical examination) (healthy subjects). subjects were matched with subjects with renal impairment (mild, moderate, severe and hemodialysis) on the basis of race, gender, age ( 10 years), and weight ( 30% of weight in pounds). Study Drug, Dose, Mode of Administration: Ramelteon 16 mg tablet, oral Lot Number: Z515A021 Duration of Treatment: The study duration for an individual subject was 10 days: a single dose of ramelteon 16 mg on the morning of Day 1 followed by a 2-day washout on Day 2 through Day 3, once daily doses of ramelteon 16 mg on the morning of Day 4 through Day 8, pharmacokinetic sampling on Day 9, and Discharge on Day 10. Reference Therapy, Dose and Mode of Administration, Lot Number: None.

4 Page 5 of 4601 Criteria for Evaluation: Pharmacokinetic: Groups A-D ( Subjects and Subjects with Mild, Moderate, or Severe ) The following serum and urine pharmacokinetic parameters were calculated for ramelteon and its metabolites on Day 1: area under concentration-time curve from time 0 to time of last quantifiable concentration (AUC[0-tlqc]), area under concentration-time curve from 0 to 48 hours (AUC[0-48]), area under concentration-time curve from 0 to infinity (AUC[0-inf]), maximum observed concentration (Cmax), time at which Cmax is observed (Tmax), terminal elimination rate constant ( z), terminal half-life (T1/2), amount excreted in urine over 48 hours postdose (XU[0-48]), and renal clearance (CLr). In addition, apparent oral clearance corrected for bioavailability (CLtotal/F) and apparent nonrenal clearance (CLnr) were calculated for unchanged ramelteon only. For M-II and M-III, XU(0-48) values were determined for the unconjugated and total forms. The following serum and urine pharmacokinetic parameters were calculated for ramelteon and its metabolites on Day 8: area under the blood concentration-time curve from time 0 to tau (AUC[0- ]), Cmax, minimum observed concentration (Cmin), Tmax, z, T1/2, XU(0- ), and CLr. In addition, CLtotal/F and CLnr were calculated for unchanged ramelteon only. For M-II and M-III, XU(0- ) values were determined for the unconjugated and total forms. Group E (Hemodialysis Subjects) The following serum pharmacokinetic parameters were calculated for ramelteon and its metabolites on Day 1: AUC(0-tlqc), AUC(0-48), AUC(0-inf), Cmax, Tmax, z, T1/2, and CLtotal/F (for unchanged ramelteon only). In addition, the dialysis extraction coefficient (ER) and the hemodialysis clearance (CLhem) were calculated for this group. The following serum pharmacokinetic parameters were calculated for ramelteon and its metabolites on Day 8: AUC(0- ), Cmax, Cmin, Tmax, z, T1/2, CLtotal/F (for unchanged ramelteon only), ER, and CLhem. Safety: Safety variables included adverse events, clinical laboratory test results, vital signs, 12-lead electrocardiograms, and physical examinations. Statistical Methods: An analysis of variance (ANOVA) with a fixed effect for subject group was performed on AUC(0-tlqc), AUC(0-inf), Cmax, z, and CLr (if available) for single dose, and AUC(0- ), Cmax, z, and CLr (if available) for multiple dose to compare the renal impairment subject (mild, moderate, severe, and hemodialysis) group to their corresponding matched healthy subject group. The natural logarithms of AUC(0-tlqc), AUC(0-inf), AUC(0- ), Cmax, and CLr were used for analysis. The 90% confidence intervals (CIs) of the mean ratios for subjects with renal impairment versus healthy control (eg, AUC[0-tlqc], severe/auc[0-tlqc], healthy) were obtained. The Kruskal-Wallis test was performed on Tmax after single and multiple doses to compare the renal impairment subject (mild, moderate, severe, and hemodialysis) group to their corresponding matched healthy subject group.

5 Page 6 of 4601 SUMMARY OF RESULTS Subject Disposition: Fifty subjects (28 men and 22 women), with a mean age of 51.0 years, were enrolled in the study. Forty-nine subjects (28 men and 21 women) completed the study. One subject was withdrawn due to adverse events (bronchitis and acute respiratory infection). Pharmacokinetic Results: Single and multiple dose pharmacokinetic parameters for ramelteon and its metabolites were evaluated in serum and urine on Day 1 and Day 8 in subjects with renal impairment and in healthy matched controls. No apparent correlation was observed between renal function (CLCr) and ramelteon or M-II exposure. In general, ramelteon and M-II Cmax and AUC values in renally impaired subjects (mild, moderate, or severe) were not markedly different from the values observed in their healthy matched controls, as demonstrated in the following figure showing the relationship between ramelteon AUC(0- ) values versus CLCr on Day 8. These findings were expected since both ramelteon and M-II are extensively metabolized and their renal excretion is <1% of the dose after oral administration in healthy subjects with normal renal function Mild Renal Impaired Moderate Renal Impaired Severe Renal Impaired AUC(0-tau) (ng hr/ml) Creatinine Clearance (ml/min)

6 Page 7 of 4601 The statistical results from the ANOVA of least squares means were based on relatively small groups of renally impaired subjects and their healthy matched controls and are summarized in the following sections. Throughout the study high levels of variability were observed (CVs for ramelteon AUC and Cmax approximately 100%) in renally impaired or healthy subjects. No statistically significant differences were found in least squares means for ramelteon and M-II AUC and Cmax values between groups of renally impaired subjects and their healthy matched control subjects; however, all 90% CIs were not contained within the 80% to 125% range. Serum Pharmacokinetics: Day 1 Results Ramelteon and M-II statistical results for subjects with renal impairment compared to healthy matched controls on Day 1 are presented in the following table. Least Squares Means Renal Mean Ratio Matched Impairment (%) 90% CI of Ratio Comparison Analyte Parameter Control (R) (T) (100 T/R) (%) P-value Mild to Ramelteon Cmax (ng/ml) (37.32, ) AUC(0-tlqc) (ng hr/ml) (42.60, ) AUC(0-inf) (ng hr/ml) (43.63, ) M-II Cmax (ng/ml) (91.80, ) AUC(0-tlqc) (ng hr/ml) (101.28, ) Moderate to AUC(0-inf) (ng hr/ml) (98.52, ) Ramelteon Cmax (ng/ml) (21.41, ) AUC(0-tlqc) (ng hr/ml) (20.40, ) AUC(0-inf) (ng hr/ml) (21.73, ) M-II Cmax (ng/ml) (45.92, ) Source: Table and Table R indicates Reference; T, Test. AUC(0-tlqc) (ng hr/ml) (48.22, ) AUC(0-inf) (ng hr/ml) (49.63, ) Least Squares Means Matched Renal Mean Control Impairment Ratio (%) 90% CI of Ratio Comparison Analyte Parameter (R) (T) (100 T/R) (%) P-value Severe to Ramelteon Cmax (ng/ml) (29.81, ) AUC(0-tlqc) (ng hr/ml) (54.15, ) AUC(0-inf) (ng hr/ml) (88.07, ) M-II Cmax (ng/ml) (59.06, ) AUC(0-tlqc) (ng hr/ml) (104.01, ) AUC(0-inf) (ng hr/ml) (104.53, )

7 Page 8 of 4601 Hemodialysis Ramelteon Cmax (ng/ml) (39.51, ) to AUC(0-tlqc) (ng hr/ml) (21.49, ) AUC(0-inf) (ng hr/ml) (16.15, ) M-II Cmax (ng/ml) (72.82, ) AUC(0-tlqc) (ng hr/ml) (47.53, ) AUC(0-inf) (ng hr/ml) (48.13, ) Source: Tables and R indicates Reference; T, Test. Generally, there was no consistent change in ramelteon and M-II exposures with increasing severity in renal impairment. Ramelteon and M-II Cmax and AUC(0-inf) were not markedly different in subjects with mild or moderate renal impairment compared to their healthy matched controls on Day 1. An approximately 4-fold increase in the ramelteon AUC value was observed in subjects with severe renal impairment, however, this increase was not statistically significantly different from their healthy matched control subjects. The increased AUC in subjects with severe renal impairment was mainly the result of 1 severely impaired subject who had high ramelteon AUC values on Day 1 (AUC[0-inf] = 166 ng hr/ml on Day 1 versus AUC[0- ] = 13.8 ng hr/ml on Day 8). Subjects on hemodialysis showed 24% and 12% increases in ramelteon and M-II Cmax values, respectively, and approximately 30% to 40% decreases in AUCs compared to their healthy matched controls on Day 1. The dialysis extraction coefficient (ER) of ramelteon was , indicating that dialysis was not an effective method for reducing systemic drug exposure. Serum Pharmacokinetics: Day 8 Results Ramelteon and M-II statistical results for subjects with renal impairment compared to healthy matched controls on Day 8 are presented in the following table. Least Squares Means Matched Renal Mean Control Impairment Ratio (%) 90% CI of Ratio Comparison Analyte Parameter (R) (T) (100 T/R) (%) P-value Mild to Ramelteon Cmax (ng/ml) (27.36, ) AUC(0- ) (ng hr/ml) (30.30, ) Moderate to Severe to M-II Cmax (ng/ml) (81.67, ) AUC(0- ) (ng hr/ml) (96.41, ) Ramelteon Cmax (ng/ml) (44.99, ) AUC(0- ) (ng hr/ml) (33.80, ) M-II Cmax (ng/ml) (68.64, ) AUC(0- ) (ng hr/ml) (47.60, ) Ramelteon Cmax (ng/ml) (36.95, ) AUC(0- ) (ng hr/ml) (53.30, ) M-II Cmax (ng/ml) (71.84, ) AUC(0- ) (ng hr/ml) (94.06, )

8 Page 9 of 4601 Hemodialysis to Ramelteon Cmax (ng/ml) (17.08, ) AUC(0- ) (ng hr/ml) (14.38, ) M-II Cmax (ng/ml) (61.03, ) AUC(0- ) (ng hr/ml) (52.71, 95.62) Source: Table , Table , Table , and Table R indicates Reference; T, Test. Similar to the Day 1 results, there was no consistent change in ramelteon and M-II exposures with increasing severity in renal impairment. Ramelteon and M-II Cmax and AUC(0- ) were not markedly different in mild or moderate renal impairment subjects compared to their healthy matched controls on Day 8. An approximately 2-fold increase in the ramelteon AUC(0- ) value was observed in subjects with severe renal impairment, however, this increase was not statistically significantly different from their healthy matched controls. Subjects on hemodialysis showed 35% and 51% decreases in ramelteon Cmax and AUC(0- ), respectively, compared to their healthy matched controls on Day 8. The ER of ramelteon was on Day 8. Safety Results: Thirty-four out of 50 (68.0%) subjects experienced at least 1 treatment-emergent adverse event. There were 94 adverse events reported within 14 days after the last dose of study medication. Six subjects with mild renal impairment (6/8; 75%) reported 24 adverse events, compared with 4 healthy matched controls (4/5; 80.0%) reporting 11 adverse events; 4 subjects with moderate renal impairment (4/5; 80.0%) reported 9 adverse events, compared with 2 healthy matched controls (2/5; 40.0%) reporting 4 adverse events; 5 subjects with severe renal impairment (5/7; 71.4%) reported 11 adverse events, compared with 5 healthy matched controls (5/7; 71.4%) reporting 19 adverse events; 7 subjects on hemodialysis (7/9; 77.8%) reported 15 adverse events, compared with 1 healthy matched control (1/4; 25.0%) reporting 1 adverse event. The percentage of subjects experiencing at least 1 treatment-emergent adverse event by gender was 64.3% (18/28) for men and 72.7% (16/22) for women. The most common adverse event reported by all subjects was somnolence (10/50; 20%). One subject had clinical laboratory values that were considered a moderate adverse event, 1 subject had an ECG finding that was considered a mild adverse event, and 3 subjects had changes in vital signs that were considered moderate adverse events. No clinically meaningful changes in physical examination findings were reported in this study. One subject was withdrawn due to an adverse event (bronchitis, acute respiratory infection; considered not related to study medication) and one subject experienced an SAE (myocardial infarction; considered not related to study medication) following completion of the study. No deaths occurred during the study.

9 Page 10 of 4601 CONCLUSIONS: The differences in peak and total exposures to ramelteon in subjects with mild, moderate, or severe renal impairment were not considered clinically meaningful compared to healthy subjects in view of the wide inter-subject variability in ramelteon exposure (CV for AUC approximately 100%). Renal clearance of ramelteon was not significantly affected by degree of renal impairment. There was no apparent correlation between renal function (CLCr) and ramelteon Cmax or AUC values in healthy subjects and subjects with mild, moderate, or severe renal impairment. These findings were expected since ramelteon is extensively metabolized and its renal excretion is negligible. The marginal differences in exposure to ramelteon s major metabolite, M-II, between subjects with renal impairment and healthy subjects were also not considered clinically meaningful. The dialysis extraction coefficients for ramelteon indicate that dialysis was not an effective method for reducing systemic drug exposure. There were no clinically meaningful differences in exposures to ramelteon and M-II in subjects on hemodialysis, which tended to be lower compared to their corresponding healthy control subjects. Single and multiple doses of ramelteon 16 mg once daily for 5 days appeared to be safe and well tolerated when administered to subjects with varying degrees of renal impairment. Date of Report: FINAL

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