Celerion
Tempe, Arizona, 85283, United States
NCT Number: NCT06290050
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).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
The drug being tested in this study is called TAK-279. The study will assess the potential effect of TAK-279 on cytochrome P450 (CYP) 3A4 using the probe substrate midazolam and the potential effect of TAK-279 on CYP2C8 using the probe substrate repaglinide in healthy participants.
The study will enroll approximately 20 participants. Participants will be enrolled in one of the four treatments.
This single-center trial will be conducted in the United States. The overall study duration is approximately 59 days including screening period and follow-up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study:
Exclusion criteria
Participants must not be enrolled in the study if they meet any of the following criteria:
Midazolam syrup.
Repaglinide tablets.
TAK-279 capsules.
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
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
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
Time frame: From Day 1 of Period 1 up to 14 days after the last dose of TAK-279 in Period 2 (up to 29 days)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. AESI (serious or nonserious) includes infections that are severe or serious; opportunistic; herpes virus; active tuberculosis (TB); or any infection requiring intravenous systemic therapy or immunomodulatory therapy, Creatine phosphokinase (CPK) elevation Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher (severe) greater than (>) 5* upper limit of normal (ULN), Liver injury, MACE (Major adverse cardiovascular events), Gastrointestinal perforation, Thromboembolic events, Malignancies including all malignancies, Nonmelanoma skin cancer (NMSC), and excluding NMSC and Lymphoma.
Takeda
Industry
A Phase 1, Open-Label, Drug-Drug Interaction Study to Assess the Effect of TAK-279 on the Pharmacokinetics of a Sensitive CYP3A4 Substrate and a Sensitive CYP2C8 Substrate in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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