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Phase 1 Completed N=12 Randomized Treatment

A Food Effect Study of TAK-385 Final Formulation

Japanese Premenopausal Healthy Adult Women
Source: ClinicalTrials.gov NCT02792062 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-385 — 23.44; 29.05; 10.94 nanogram per milliliter (ng/mL) — p=0.659

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Cmax: Maximum Observed Plasma Concentration for TAK-385
23.44; 29.05; 10.94 0.659
PRIMARY
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
160.5; 139.1; 79.65 0.238
PRIMARY
AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
149.3; 130.2; 73.25 0.256
PRIMARY
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
149.3; 130.2; 73.25 0.256
SECONDARY
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
5; 5; 3; 0; 0; 0
SECONDARY
Number of Participants With TEAEs Related to Vital Signs (Presyncope)
0; 1; 0
SECONDARY
Number of Participants With TEAEs Related to Body Weight
0; 0; 0
SECONDARY
Number of Participants With TEAEs Related to Electrocardiograms (ECG)
0; 0; 0
SECONDARY
Number of Participants With TEAEs Related to Clinical Laboratory Tests
0; 0; 0

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 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.
  • 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 arrhythmia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02792062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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