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

Sponsor
Amgen
Study ID
NCT06061523
Phase
PHASE1
Status
Withdrawn

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Apr 2024
Primary completion
Sep 9, 2024
Completion
Sep 9, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment Sequence ABC
    Participants will be administered sotorasib orally in the following order: Treatment A - as 4 tablets under fasting conditions (test) Treatment B - as 8 tablets under fasting conditions (reference) Treatment C - as 4 tablets under fed conditions (test)
  • Experimental: Treatment Sequence BAC
    Participants will be administered sotorasib orally in the following order: Treatment B - as 8 tablets under fasting conditions (reference) Treatment A - as 4 tablets under fasting conditions (test) Treatment C - as 4 tablets under fed conditions (test)

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Sotorasib [ Time Frame: Approximately 9 days ]

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