Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects

NCT02578953 | Completed Phase 1

• 1 other identifier: 204646
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single center, open-label, single dose, randomized and 2-way crossover study in healthy Japanese male subjects under fasting conditions. The study will be conducted to determine the bioequivalence between dutasteride capsules manufactured at GSK (test product) and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male subjects. Subjects will have a screening visit within 30 days prior to the first dose of study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14 days after the second dose for the first follow-up and a second follow up via telephone 50-54 days after the second dose. The total duration of the study will be approximately 15 weeks from screening to the second follow up.

Conditions

Prostatic Hyperplasia

Keywords

Bioequivalence; Fasted state; Japanese male healthy subjects; Dutasteride

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product

  Blood samples will be collected for PK analyses in each period before dosing (0 hour) and at the following times after the dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours.

  Pre-dose and at the following times post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours) in each period.

• Maximal measured plasma concentration (Cmax) of dutasteride test product and reference product

  Blood samples will be collected for PK analyses in each period before dosing (0 hour) and at the following times after the dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours.

  Pre-dose and at the following times post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours) in each period

Secondary Outcomes (18)

• Number of subjects with adverse events

  Approximately 12 weeks

• Change from Baseline in hematology parameters

  Baseline (screening or Day-1) and Day 2 of each treatment period.

• Change from Baseline in clinical chemistry parameters

  Baseline (screening or Day-1) and Day 2 of each treatment period.

• Change from Baseline in routine urinalysis parameters

  Baseline (screening or Day-1) and Day 2 of each treatment period.

• Change from Baseline in systolic and diastolic blood pressure measurements

  Baseline (screening) and Day 1and Day 2 of each treatment period and at first follow-up visit (approximately up to 11 weeks).

Study Arms (2)

Sequence 1-Dutasteride test product and then Reference product

EXPERIMENTAL

Participants will receive treatment A in period 1 and treatment B in period 2. Where treatment A= dutasteride 0.5 mg capsule test product, treatment B= dutasteride 0.5 mg capsule reference product.

Drug: Dutasteride-Test product; Drug: Dutasteride-Reference product

Sequence 2-Dutasteride reference product and then test product

EXPERIMENTAL

Participants will receive treatment B in period 1 and treatment A in period 2. Where treatment A= dutasteride 0.5 mg capsule test product, treatment B= dutasteride 0.5 mg capsule reference product.

Drug: Dutasteride-Test product; Drug: Dutasteride-Reference product

Interventions

Dutasteride-Test product DRUG

Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by GSK, Poznan.

Sequence 1-Dutasteride test product and then Reference product; Sequence 2-Dutasteride reference product and then test product

Dutasteride-Reference product DRUG

Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Glycerin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by Catalent, Beinheim.

Sequence 1-Dutasteride test product and then Reference product; Sequence 2-Dutasteride reference product and then test product

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 and 64 years of age inclusive, at the time of signing the informed consent.

You may not qualify if:

• Body weight \>=50 kilograms (kg) and body mass index (BMI) within the range 18.5-24.9 kg/meter squared at screening.
• Japanese male.
• Male subjects with female partners of child bearing potential must comply with the contraception requirements from the time of first dose of study medication until the second follow-up.
• Capable of giving signed informed consent as described in which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
• ALT and bilirubin \>1.5xupper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Corrected QT interval (QTc) \>450 milliseconds (msec).
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• History of myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident.
• History of diabetes or peptic ulcer disease which is uncontrolled by medical management.
• History of breast cancer or clinical breast examination finding suggestive of malignancy.
• History of malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
• Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or suspicious ultrasound, or suspicious digital rectal examination (DRE)). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable prostate specific antigen (PSA) are eligible for the study.
• Creatinine \>1.5xULN.
• History or current conditions of drug abuse or alcoholism.
• Unable to refrain from the use of prescription drugs, non- prescription drugs, vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fukuoka, 813-0017, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 204646 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Prostatic Hyperplasia; Fasting

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: October 19, 2015
• Study Start: September 9, 2015
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)