Terminated/Withdrawn
Sponsor ID
20220098

A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

Sponsor ID
20220098
Clinicaltrials.gov ID
NCT06061523
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objectives of the study are to compare the pharmacokinetics (PK) and demonstrate relative bioavailability of sotorasib administered as 4 oral tablets (test) to sotorasib administered as 8 oral tablets (reference) and to assess the effect of food on the PK of sotorasib administered as 4 oral tablets.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
0
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Sotorasib

Timeframe: Approximately 9 days

Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib

Timeframe: Approximately 9 days

Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib

Timeframe: Approximately 9 days

Secondary Outcome Measures

Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Approximately 9 days

Number of Participants who Experience a Serious Adverse Event (SAE)

Timeframe: Up to approximately 39 days

Locations

No locations found.