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

Healthy Participants Clinical Trial

Official title:

An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327491
• Other study ID #: 20210088
• Status: Completed
• Phase: Phase 1
• Start date: March 21, 2022
• Est. completion date: July 17, 2022

Study information

• Verified date: March 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 17, 2022
• Est. primary completion date: July 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Sotorasib
Oral Tablet

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit - Dallas	Dallas	Texas
United States	Labcorp Clinical Research Unit - Daytona Beach	Daytona Beach	Florida
United States	Labcorp Clinical Research Unit - Madison	Madison	Wisconsin
United States	Miami Research Associates LLC - Main Campus / Late Phase	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4)
Primary	Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4)
Primary	Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of each period (Days 1 and 4)
Secondary	Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)	A TEAE was defined as an adverse event (AE) that started during or after dosing, or started prior to dosing and increased in severity after dosing within each period.; Clinically significant laboratory tests, 12-lead electrocardiogram (ECG), or vital sign results as assessed by the Investigator were also recorded as adverse events.	Day 1 to Day 9
Secondary	Period 3: Cmax of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7)
Secondary	Period 3: AUClast of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of Period 3 (Day 7)
Secondary	Period 3: AUCinf of Sotorasib		Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7)

External Links

•   AmgenTrials clinical trials website