A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Takeda
Study ID
NCT06290050
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Midazolam — DRUG
    Midazolam syrup.
  • Repaglinide — DRUG
    Repaglinide tablets.
  • TAK-279 — DRUG
    TAK-279 capsules.

Study Details

The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).

Key Dates

Start date
Mar 29, 2024
Status verified
May 2024
Primary completion
May 3, 2024
Completion
May 16, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Treatment A: Midazolam 2 mg
    Midazolam 2 mg (1 milliliter \[mL\] of 2 milligram per milliliter \[mg/mL\]), syrup, orally, on Day 1 of Period 1.
  • Experimental: Treatment B: Repaglinide 0.5 mg
    Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 2 of Period 1.
  • Experimental: Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg
    TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2.
  • Experimental: Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg
    TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 15 of Period 2.

Primary Outcome Measure

Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 [ Time Frame: Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

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By research site
Celerion· Tempe, AZ

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