A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects

NCT02093390 | Completed Phase 1 Results

• 2 other identifiers: C27005U1111-1183-0138
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.

Conditions

Prostate Cancer; Endometriosis

Outcome Measures

Primary Outcomes (6)

• Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1

  Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 1 (Predose and multiple time points up to 120 hours postdose)

• Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10

  Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 10 (Predose and multiple time points up to 120 hours postdose)

• AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1

  Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.

  Day 1 (Predose and multiple time points up to 120 hours postdose)

• AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10

  Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.

  Day 10 (Predose and multiple time points up to 120 hours postdose)

• AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1

  Area under the plasma concentration-time curve from time 0 to infinity.

  Day 1 (Predose and multiple time points up to 120 hours postdose)

• AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10

  Area under the plasma concentration-time curve from time 0 to infinity.

  Day 10 (Predose and multiple time points up to 120 hours postdose)

Secondary Outcomes (11)

• Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)

  First dose of study drug through the end of the study (22 days ± 3 days)

• Number of Participants With Clinical Significant Changes in Vital Signs

  Baseline and First dose of study drug through the end of the study (22 days ± 3 days)

• Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings

  Baseline and First dose of study drug through Day 15

• Number of Participants With Clinical Significant Changes in Laboratory Tests

  Baseline and First dose of study drug through the end of the study (22 days ± 3 days)

• Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385

  Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)

Study Arms (2)

TAK-385 + fluconazole

EXPERIMENTAL

TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.

Drug: TAK-385; Drug: Fluconazole

TAK-385 + atorvastatin

EXPERIMENTAL

TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.

Drug: TAK-385; Drug: Atorvastatin

Interventions

TAK-385 DRUG

TAK-385 tablets

TAK-385 + atorvastatin; TAK-385 + fluconazole

Fluconazole DRUG

Fluconazole tablets

TAK-385 + fluconazole

Atorvastatin DRUG

Atorvastatin tablets

TAK-385 + atorvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55 years, inclusive, at the time of consent.
• Healthy adult male or female in good health, as determined by a physician evaluation
• Weight ≥ 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
• Nonsmoker and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).

You may not qualify if:

• The subject has a history of drug abuse (defined as any illicit drug use) within 1 year before screening or is unwilling to abstain from drugs throughout the study.
• The subject is unwilling to agree to abstain from caffeine and alcohol-containing products from 72 hours before check-in (Day -1) to completion of the final assessment.
• The subject has taken any prescription medicine or herbal preparations (eg, St John's wort) or received any immunizations within 30 days before check-in (Day -1).
• The subject has taken any over the counter (OTC) medications or vitamin supplements within 14 days before check-in (Day -1). The subject is unwilling to agree to abstain from consumption of grapefruit or grapefruit-containing products from 72 hours before check-in (Day -1) to completion of the final assessment.
• The subject has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs.
• The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or antigen, or serological reactions for syphilis at screening.
• The subject has a clinically significant ECG abnormality at screening or check-in (Day -1) or a QTc interval (by Fridericia's correction) of 450 msec or greater, or the subject has a history of cardiac disease.
• The subject has abnormal laboratory values suggesting a clinically significant disease at screening or check-in (Day -1) .
• Female subjects who are lactating and breastfeeding or pregnant before the first dose of study drug.
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Endometriosis

Interventions

relugolix; Fluconazole; Atorvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 21, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-06