A Study to Assess the Effect of Food on the Drug Levels of Admilparant

NCT07225647 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1052
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the effect of food on the drug levels of Admilparant

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• 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

Study Arms (4)

Part 1: Treatment A

EXPERIMENTAL

Drug: Admilparant

Part 1: Treatment B

EXPERIMENTAL

Drug: Admilparant

Part 2: Treatment C

EXPERIMENTAL

Drug: Admilparant

Part 2: Treatment D

EXPERIMENTAL

Drug: Admilparant

Interventions

Admilparant DRUG

Specified dose on specified days

Part 1: Treatment A; Part 1: Treatment B; Part 2: Treatment C; Part 2: Treatment D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0002

Lenexa, Kansas, 66219-9746, United States

Location

Local Institution - 0001

Salt Lake City, Utah, 84124-1365, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: November 7, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (2)