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

Prostate Cancer Clinical Trial

Official title:

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Fluconazole and Atorvastatin on the Pharmacokinetics of a Single Oral Dose of TAK-385 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093390
• Other study ID #: C27005
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2014
• Last updated: April 30, 2014
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

Each subject must meet all the following inclusion criteria to be enrolled in the study:

1. Age 18 to 55 years, inclusive, at the time of consent.

2. Healthy adult male or female in good health, as determined by a physician evaluation

3. Weight = 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.

4. Nonsmoker and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).

Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.

1. 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.

2. 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.

3. 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).

4. The subject has taken any 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.

5. The subject has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs.

6. 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.

7. 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.

8. The subject has abnormal laboratory values suggesting a clinically significant disease at screening or check-in (Day -1) .

9. Female subjects who are lactating and breastfeeding or pregnant before the first dose of study drug.

10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Prostate Cancer

Intervention

Drug:
• TAK-385

• Fluconazole

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK assessments: maximum concentration (Cmax), AUC from time 0 to the time of the last measurable concentration (AUC0-tlast), and AUC from time 0 extrapolated to infinity (AUC0-inf) of TAK-385.		Day 1 and Day 10	No
Secondary	Safety assessments: AEs, vital signs, ECG, and clinical laboratory tests		First dose of study drug through the end of the study (22 days ± 3 days)	Yes
Secondary	PK assessments	Time to Cmax (Tmax), AUC from time 0 to 120 hours (AUC0-120), t1/2, apparent clearance (CL/F), and Fe of TAK-385.	Days 1 and 10	No
Secondary	PK assessments-Attainment of steady-state of fluconazole or atorvastatin		Days 8-12	No