A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Sponsor
NewAmsterdam Pharma
Study ID
NCT06547359
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2024
Primary completion
Nov 12, 2024
Completion
Nov 12, 2024

Study Design

Enrollment
94 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: obicetrapib with and without co-administration of ezetimibe
    Ezetimibe 10mg tablets daily from Days 1-17 plus obicetrapib 10mg tablets on Day -9 and Day 8
  • Active Comparator: ezetimibe with and without co-administration of obicetrapib
    Obicetrapib 10mg tablets daily from Days 1-15 plus ezetimibe10mg tablets on Day -3 and Day 12

Primary Outcome Measure

Cmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide) [ Time Frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days ]

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