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

Amgen

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Sotorasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06061523

20220098

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
• Body mass index, between 18 and 32 kg/m2 (inclusive), at the time of Screening
• Females of nonchildbearing potential
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).

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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
• History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair. History of cholecystectomy is not permitted.
• Estimated glomerular filtration rate (eGFR) less than 70 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease (MDRD) equation, at Screening or Check-in.
• ALT or AST > ULN, at Screening or Check-in.
• Thyroid-stimulating hormone outside normal range.
• Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test, at Screening. Participants whose results are compatible with prior immunity (vaccination or prior infection) may be included.
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before enrollment. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed. Hormone-replacement therapy (e.g., estrogen) will be allowed.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment Sequence ABC

Experimental group

Description:

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)

Treatment:

Drug: Sotorasib

Treatment Sequence BAC

Experimental group

Description:

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)

Treatment:

Drug: Sotorasib