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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Endometriosis; Prostate Cancer

Treatments: Drug: Atorvastatin; Drug: Fluconazole; Drug: TAK-385

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093390

U1111-1183-0138 (Registry Identifier)

C27005

Details and patient eligibility

About

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.

Full description

The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.

The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:

• TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14
• TAK-385 40 mg and atorvastatin 80 mg on Days 6-14

Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.

This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

TAK-385 + fluconazole

Experimental group

Description:

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.

Treatment:

Drug: Fluconazole

Drug: TAK-385

TAK-385 + atorvastatin

Experimental group

Description:

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.

Treatment:

Drug: Atorvastatin

Drug: TAK-385