A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

Sponsor
NewAmsterdam Pharma
Study ID
NCT06081166
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Obicetrapib — DRUG
    obicetrapib 10 mg daily
  • Atorvastatin Calcium — DRUG
    Atorvastatin 80 mg
  • Rosuvastatin Calcium — DRUG
    Rosuvastatin 40 mg

Study Details

A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin

Key Dates

Start date
Nov 11, 2023
Status verified
Oct 2023
Primary completion
Dec 2, 2023
Completion
Jan 22, 2024

Study Design

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

Arms

  • Active Comparator: obicetrapib + atorvastatin
    Obicetrapib 10 mg tablets daily from Days 1-17 plus atorvastatin calcium 80 mg tablets on Day -4 and Day 12
  • Active Comparator: obicetrapib + rosuvastatin
    Obicetrapib 10 mg tablets daily from Days 1-17 plus rosuvastatin calcium 40 mg tablets on Day -4 and Day 12

Primary Outcome Measure

Measure atorvastatin/rosuvastatin levels in the blood [ Time Frame: zero (0) to time of the last measurable analyte concentration (t), up to 22 days ]

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