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Clinical Trial NCT07225647 for Healthy Participants is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Bristol-Myers SquibbA Study to Assess the Effect of Food on the Drug Levels of Admilparant Phase 1 56
Clinical Trial NCT07225647 was designed to study Treatment for Healthy Participants. This was a Phase 1 interventional study that is now completed. The study started on November 7, 2025, with plans to enroll 56 participants. Led by Bristol-Myers Squibb, the expected completion date was January 5, 2026. The latest data from ClinicalTrials.gov was last updated on January 14, 2026.
Brief Summary
The purpose of this study is to assess the effect of food on the drug levels of Admilparant
Official Title
An Open-Label, Randomized, Two-part Study in Healthy Participants to Assess the Food Effect on the Pharmacokinetics of Admilparant To-Be-Marketed Tablet Formulations
Conditions
Healthy ParticipantsOther Study IDs
- IM027-1052
NCT ID Number
Start Date (Actual)
2025-11-07
Last Update Posted
2026-01-14
Completion Date (Estimated)
2026-01-05
Enrollment (Estimated)
56
Study Type
Interventional
PHASE
Phase 1
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart 1: Treatment A | Admilparant Specified dose on specified days |
ExperimentalPart 1: Treatment B | Admilparant Specified dose on specified days |
ExperimentalPart 2: Treatment C | Admilparant Specified dose on specified days |
ExperimentalPart 2: Treatment D | Admilparant Specified dose on specified days |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Maximum observed plasma concentration (Cmax) | Up to 13 days | |
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 13 days | |
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to 13 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time of maximum observed plasma concentration (Tmax) | Up to 13 days | |
Terminal half-life (T-HALF) | Up to 13 days | |
Apparent total body clearance (CLT/F) | Up to 13 days | |
Apparent volume of distribution (Vz/F) | Up to 13 days | |
Number of participants with adverse events (AEs) | Up to 13 days | |
Number of participants with a change in clinical laboratory values | Up to 13 days | |
Number of participants with a change in vital sign measurements | Up to 13 days | |
Number of participants with a change in physical examination results | Up to 13 days | |
Number of participants with a change in 12-lead electrocardiogram (ECG) results | Up to 13 days |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.
- Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participants must not have had any previous exposure to Admilparant.
- Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Bristol-Myers SquibbNo contact data.
2 Study Locations in 1 Countries
Kansas
Local Institution - 0002, Lenexa, Kansas, 66219-9746, United States
Utah
Local Institution - 0001, Salt Lake City, Utah, 84124-1365, United States