Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
NCT06050291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2024-06-05
Summary
This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.
Conditions
- Healthy Volunteer Study
Interventions
- DRUG
-
Fixed-Dose Combination (FDC) Tablet
Obicetrapib/Ezetimibe FDC tablet
Sponsors & Collaborators
-
NewAmsterdam Pharma
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-20
- Primary Completion
- 2024-04-07
- Completion
- 2024-04-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
NCT02063581 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
NCT05160389 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
NCT04466514 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
NCT02475135 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers
NCT02182414 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants
NCT01249131 ·Status: COMPLETED ·Phase: PHASE1
-
Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
NCT02536391 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
NCT03420092 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
NCT02006537 ·Status: COMPLETED ·Phase: PHASE1
-
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
NCT06048302 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants
NCT05123079 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability Study of K0706 in Healthy Subjects
NCT03316820 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
NCT03837964 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers
NCT02171026 ·Status: COMPLETED ·Phase: PHASE1
-
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
NCT01951599 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers
NCT02172209 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Baricitinib in Healthy Japanese Participants
NCT02263911 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability Study in Healthy Subjects
NCT00924911 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS
NCT02180503 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
NCT02071121 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
NCT05512806 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810
NCT02722018 ·Status: COMPLETED ·Phase: PHASE1