Japanese Premenopausal Healthy Adult WomenPhase 1NCT02792062

A Food Effect Study of TAK-385 Final Formulation

A Phase 1 study testing TAK-385 40 mg in people with Japanese Premenopausal Healthy Adult Women, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Japanese Premenopausal Healthy Adult Women
What is being tested?: TAK-385 40 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: 4 Jul 2016to 31 Aug 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug in Period 1.
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.

Show all 24Show fewer

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.
The participant has used oral contraceptive or sex hormone preparations (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins) within 8 weeks (56 days) prior to hospitalization in Period 1 (Day -1), or gonadotropin-releasing hormone (GnRH) analogues, dienogest, danazol, or aromatase inhibitors within 16 weeks (112 days) prior to hospitalization in Period 1 (Day -1) [within 20 weeks (140 days) and 28 weeks (196 days) prior to hospitalization for 1- and 3-month sustained preparations, respectively].
The participant is pregnant or lactating or intending to become pregnant before the time of informed consent, during the study, or within 1 month after completing in this study; or intending to donate ova during such time period.
The participant has evidence of current cardiovascular disease, central nervous system disease, hepatic disease, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, thromboembolism, seizures, allergic skin rash, gastrointestinal disease (pseudomembranous colitis), or mental disorder (especially depression-like symptoms) and resultant suicide attempt. The participant has a medical history, physical examination finding, or safety laboratory test finding reasonably indicative of a disease that would contraindicate GnRH analogues, or may interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
The participant has current or recent (within 6 months) gastrointestinal disease that may influence the absorption of drugs (that is, malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical intervention).
The participant has a history of cancer.
The participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, or serological reactions for syphilis at Screening.
The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to hospitalization in Period 1 (Day -1), or is unwilling to agree to stop using these products throughout the study.
The participant has poor peripheral venous access.
The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The participant has undergone whole blood collection of at least 400 mL in total within 52 weeks (364 days) prior to the start of study drug administration in Period 1.
The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration in Period 1.
The participant has a clinically significant abnormal electrocardiogram (ECG) at Screening or prior to study drug administration in Period 1.
The participant has abnormal laboratory values that suggest a clinically significant underlying disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>)1.5 the upper limits of normal at Screening or prior to study drug administration in Period 1.
The participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka, Fukuoka

Other trials in Japan

About this study

Official title: 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

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.

Read the 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.

Conditions: Japanese Premenopausal Healthy Adult Women
Being tested: TAK-385 40 mg
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-385 40 mgDrug
TAK-385 40 mg tablet

Study groups in NCT02792062
Study group	Role	What they receive
TAK-385 40 mg (Group A)	Experimental	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. Receives: Drug: TAK-385 40 mg
TAK-385 40 mg (Group B)	Experimental	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. Receives: Drug: TAK-385 40 mg
TAK-385 40 mg (Group C)	Experimental	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. Receives: Drug: TAK-385 40 mg
TAK-385 40 mg (Group D)	Experimental	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. Receives: Drug: TAK-385 40 mg
TAK-385 40 mg (Group E)	Experimental	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. Receives: Drug: TAK-385 40 mg
TAK-385 40 mg (Group F)	Experimental	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. Receives: Drug: TAK-385 40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for TAK-385
Measured: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Measured: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
Measured: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
Measured: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose

Secondary outcomes (5)

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
Measured: Day 1 up to 12 days after the last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Vital Signs (Presyncope)
Measured: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Body Weight
Measured: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Electrocardiograms (ECG)
Measured: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Clinical Laboratory Tests
Clinical laboratory tests included hematology, serum chemistry, and urinalysis.
Measured: Day 1 up to 12 days after last dose of study drug (Day 41)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jul 201631 Aug 2016

First posted7 Jun 2016 (estimated)
Study start4 Jul 2016
Primary completion31 Aug 2016
Study completion31 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Japanese Premenopausal Healthy Adult WomenStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02792062
Sponsor's protocol ID: TAK-385-1011
Other IDs: JapicCTI-163273, U1111-1183-0020
Status last verified: Nov 2017
First submitted: 2 Jun 2016
Last updated: 18 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02792062
Acronym / sponsor ID: TAK-385-1011
Conditions: Japanese Premenopausal Healthy Adult Women
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 4 Jul 2016 (actual)
Primary completion: 31 Aug 2016 (actual)
Study completion: 31 Aug 2016 (actual)
First posted: 7 Jun 2016 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
TAK-385 40 mg (Group A)	Experimental	Drug: TAK-385 40 mgA 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.
TAK-385 40 mg (Group B)	Experimental	Drug: TAK-385 40 mgA 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.
TAK-385 40 mg (Group C)	Experimental	Drug: TAK-385 40 mgA 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.
TAK-385 40 mg (Group D)	Experimental	Drug: TAK-385 40 mgA 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.
TAK-385 40 mg (Group E)	Experimental	Drug: TAK-385 40 mgA 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.
TAK-385 40 mg (Group F)	Experimental	Drug: TAK-385 40 mgA 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.

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (24 listed)

The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug in Period 1.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-385 40 mgTAK-385 40 mg tablet	Drug	TAK-385 40 mg (Group A), TAK-385 40 mg (Group B), TAK-385 40 mg (Group C), TAK-385 40 mg (Group D), TAK-385 40 mg (Group E), TAK-385 40 mg (Group F)

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-385
Time frame: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose

5 secondary outcomes

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
Time frame: Day 1 up to 12 days after the last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Vital Signs (Presyncope)
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Body Weight
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Electrocardiograms (ECG)
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Number of Participants With TEAEs Related to Clinical Laboratory Tests
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-385: Fasted+ Before Breakfast + After Breakfast	2	2
TAK-385: Before Breakfast+ After Breakfast + Fasted	2	2
TAK-385: After Breakfast+ Fasted + Before Breakfast	2	2
TAK-385: Fasted+ After Breakfast + Before Breakfast	2	2
TAK-385: Before Breakfast+ Fasted + After Breakfast	2	2
TAK-385: After Breakfast+ Before Breakfast + Fasted	2	2

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-385

Time frame: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-385 40 mg Fasted n = 12	TAK-385 40 mg Before Breakfast n = 12	TAK-385 40 mg After Breakfast n = 11
Value	23.44 (17.822)	29.05 (22.868)	10.94 (9.3726)

TAK-385 40 mg Fasted vs TAK-385 40 mg Before Breakfast: Least Square Mean Ratio (%): 113.06 (90% CI 70.37 to 181.67), p = 0.659, Mixed Models Analysis
TAK-385 40 mg Fasted vs TAK-385 40 mg After Breakfast: Least Square Mean Ratio (%): 45.43 (90% CI 27.86 to 74.07), p = 0.012, Mixed Models Analysis

Population analysed: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385

Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose. Mean (Standard Deviation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	TAK-385 40 mg Fasted n = 12	TAK-385 40 mg Before Breakfast n = 12	TAK-385 40 mg After Breakfast n = 11
Value	160.5 (75.187)	139.1 (65.653)	79.65 (33.426)

TAK-385 40 mg Fasted vs TAK-385 40 mg Before Breakfast: Least Square Mean Ratio (%): 84.28 (90% CI 66.09 to 107.47), p = 0.238, Mixed Models Analysis
TAK-385 40 mg Fasted vs TAK-385 40 mg After Breakfast: Least Square Mean Ratio (%): 53.20 (90% CI 41.39 to 68.37), p <0.001, Mixed Models Analysis

Primary outcome: AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385

Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-385 40 mg Fasted n = 12	TAK-385 40 mg Before Breakfast n = 12	TAK-385 40 mg After Breakfast n = 11
Value	149.3 (70.354)	130.2 (61.549)	73.25 (30.726)

TAK-385 40 mg Fasted vs TAK-385 40 mg Before Breakfast: Least Square Mean Ratio (%): 84.68 (90% CI 66.23 to 108.27), p = 0.256, Mixed Models Analysis
TAK-385 40 mg Fasted vs TAK-385 40 mg After Breakfast: Least Square Mean Ratio (%): 52.56 (90% CI 40.78 to 67.74), p <0.001, Mixed Models Analysis

Primary outcome: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385

Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-385 40 mg Fasted n = 12	TAK-385 40 mg Before Breakfast n = 12	TAK-385 40 mg After Breakfast n = 11
Value	149.3 (70.354)	130.2 (61.549)	73.25 (30.726)

TAK-385 40 mg Fasted vs TAK-385 40 mg Before Breakfast: Least Square Mean Ratio (%): 84.68 (90% CI 66.23 to 108.27), p = 0.256, Mixed Models Analysis
TAK-385 40 mg Fasted vs TAK-385 40 mg After Breakfast: Least Square Mean Ratio (%): 52.56 (90% CI 40.78 to 67.74), p <0.001, Mixed Models Analysis

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-385 40 mg Fasted	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
TAK-385 40 mg Before Breakfast	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
TAK-385 40 mg After Breakfast	0 of 11 (0%)	3 of 11 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-385 40 mg in people with Japanese Premenopausal Healthy Adult Women, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for TAK-385 (time frame: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.