A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Takeda
Study ID
NCT05995249
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TAK-279 — DRUG
    TAK-279 capsules
  • Erythromycin — DRUG
    Erythromycin tablets
  • Phenytoin — DRUG
    Phenytoin capsules
  • Efavirenz — DRUG
    Efavirenz tablets

Study Details

The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism. The participants will need to stay at the clinic for up to 26 days.

Key Dates

Start date
Aug 11, 2023
Status verified
Feb 2024
Primary completion
Dec 18, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
172 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
    Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.
  • Experimental: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
    Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.
  • Experimental: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
    Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.

Primary Outcome Measure

Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279 [ Time Frame: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion - Tempe, AZ SiteTempeArizona85283-

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Celerion - Tempe, AZ Site· Tempe, AZ

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