Not yet recruiting NCT07723118
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adagrasib.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1, Single-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent
Overview
The aim of this study is to assess the pharmacokinetics, safety and tolerability of single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent
Interventions
- Drug Adagrasib
Specified dose on specified days
Primary outcome measures
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to Day 7]
- Time of Maximum Observed Plasma Concentration [Time frame: Up to Day 7]
- Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] [Time frame: Up to Day 7]
- Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] [Time frame: Up to Day 7]
- Apparent Terminal Phase Half-life (T-HALF) [Time frame: Up to Day 7]
- Apparent Total Body Clearance (CLT/F) [Time frame: Up to Day 7]
- Volume of Distribution of Terminal Phase (Vz/F) [Time frame: Up to Day 7]
Secondary outcome measures (5)
- Number of Participants with Treatment Emergent Adverse Events (AEs) [Time frame: Up to Day 13]
- Number of Participants with Clinical Laboratory Test Abnormalities [Time frame: Up to Day 7]
- Number of Participants with Vital Sign Abnormalities [Time frame: Up to Day 7]
- Number of Participants with Physical Examination (PE) Abnormalities [Time frame: Up to Day 7]
- Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities [Time frame: Up to Day 7]
Eligibility criteria
Inclusion criteria
- Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).
- Participants must be healthy adult without clinically significant deviation from normal in medical history, PE, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
- Participants must have Body mass index of 18.0 kg/m2 to 32.0 kg/m2.
- Participants must have Total body weight ≥ 50 kg.
Exclusion criteria
- Participants must not have significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
- Other protocol defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Local Institution - 0001 — Anaheim
Identifiers
NCT: NCT07723118 · CA239-0028