Clinical trial NCT02792062
Conditions: Japanese Premenopausal Healthy Adult Women
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2016-07-04; Completion date: 2016-08-31
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Arms: arm 1: 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. arm 2: A single oral dose of TAK-385 40 mg (one tablet) before 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) after 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) in fasted condition without breakfast in Period 3. arm 3: A single oral dose of TAK-385 40 mg (one tablet) after 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) in fasted condition without 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) before breakfast in Period 3. arm 4: A single oral dose of TAK-385 40 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) after 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) before breakfast in Period 3. arm 5: A single oral dose of TAK-385 40 mg (one tablet) before 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) in fasted condition without 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. arm 6: A single oral dose of TAK-385 40 mg (one tablet) after 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) in fasted condition without breakfast in Period 3.
Interventions: intervention 1: TAK-385 40 mg
Intervention descriptions: intervention 1: TAK-385 40 mg tablet

Protocol documents: