A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

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Amgen

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Sotorasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05327491
20210088

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

146 participants in 2 patient groups

Treatment Sequence ABC
Experimental group
Description:
Participants will be administered sotorasib orally in the following order: Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2)
Treatment:
Drug: Sotorasib
Treatment Sequence BAC
Experimental group
Description:
Participants will be administered sotorasib orally in the following order: Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2)
Treatment:
Drug: Sotorasib

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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