A Phase 1, Randomized, Open-label, Crossover Study to Assess Food Effect on Single Oral Dose Administration of TAK-385 Final Formulation in Premenopausal Healthy Adult Women

Takeda0 sites12 target enrollmentJuly 4, 2016

ConditionsJapanese Premenopausal Healthy Adult Women

InterventionsTAK-385 40 mg

DrugsTAK-385 40 mg

Overview

Phase: Phase 1
Intervention: TAK-385 40 mg
Conditions: Japanese Premenopausal Healthy Adult Women
Sponsor: Takeda
Enrollment: 12
Primary Endpoint: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.

Detailed Description

This is a phase 1 clinical pharmacological study of TAK-385 in Japanese premenopausal healthy adult women. Using an open-label crossover design, food effects on the pharmacokinetics and safety of TAK-385 will be evaluated in participants receiving a single oral dose of TAK-385 40 mg in fasted condition without breakfast, before breakfast, or after breakfast. Participants determined to be eligible will be randomly assigned to one of Groups A to F prior to study medication administration in Period 1; subsequently, participants will receive one TAK-385 40 mg tablet in fasted condition without breakfast (following a minimum 10-hour overnight fast), before breakfast (30 minutes before starting breakfast), or after breakfast (30 minutes after starting breakfast) in Periods 1, 2, and 3.

Registry

clinicaltrials.gov

Start Date

July 4, 2016

End Date

August 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Takeda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
•The participant is a Japanese premenopausal healthy adult woman.
•The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
•The participant weighs at least 40.0 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25.0 kilogram per square meter (kg/m\^2), inclusive at Screening.
•A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the time of signing the informed consent form throughout the duration of the study.
•The participant has experienced 3 or more consecutive regular menstrual cycles prior to the time of informed consent.

Exclusion Criteria

•The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug in Period
•The participant has received TAK-385 in a previous clinical study.
•The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
•The participant has uncontrolled, clinically significant neurological, circulatory, pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary, or endocrine disease, or other abnormality, which may impact the ability of the participant to participate in the study or potentially confound the study results.
•The participant has a diagnosis of abnormal menstruation.
•The participant has undiagnosable abnormal genital bleeding.
•The participant has a known hypersensitivity or allergy to drugs.
•The participant has a positive urine drug test result for drug abuse or positive breath alcohol test result at Screening.
•The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
•The participant has taken any excluded medication, supplements, or food products during the time periods listed in the Prohibited Medications and Dietary Products table.

Arms & Interventions

TAK-385 40 mg (Group A)

A single oral dose of TAK-385 40 milligram (mg) (one tablet) in fasted condition without breakfast in Period 1, followed by a minimum 14-day washout period between study drugs, further followed by a single oral dose of TAK-385 40 mg (one tablet) before breakfast in Period 2, followed by a minimum 14-day washout period between study drugs and further followed by a single oral dose of TAK-385 40 mg (one tablet) after breakfast in Period 3.