Study Complete
Sponsor ID
20210093

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Sponsor ID
20210093
Clinicaltrials.gov ID
NCT05048784
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
145
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Sotorasib

Timeframe: 6 days

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

Timeframe: 6 days

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

Timeframe: 6 days

Secondary Outcome Measures

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

Timeframe: 9 days

Maximum Observed Plasma Concentration (Cmax) of Sotorasib

Timeframe: 3 days

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

Timeframe: 3 days

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

Timeframe: 3 days

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Status
Recruiting
Location
Covance Clinical Research Unit
Dallas, Texas, United States, 75247
Status
Recruiting