Phase 1
Completed N=146
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Healthy Participants
Source: ClinicalTrials.gov NCT05327491 ↗
Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib — 4170; 4340 ng/mL
Summary
The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib |
4170; 4340 | — |
| PRIMARY Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib |
15300; 15800 | — |
| PRIMARY Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib |
15500; 16100 | — |
| SECONDARY Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) |
3; 10; 0 | — |
| SECONDARY Period 3: Cmax of Sotorasib |
4530 | — |
| SECONDARY Period 3: AUClast of Sotorasib |
19000 | — |
| SECONDARY Period 3: AUCinf of Sotorasib |
19100 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.
- Females of nonchildbearing potential.
Exclusion Criteria
- Inability to swallow oral medication or history of malabsorption syndrome.
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- Poor peripheral venous access.
- History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants safety or interfere with the study evaluation, procedures, or completion.
Data sourced from ClinicalTrials.gov (NCT05327491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.