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Study Complete
Sponsor ID
20190319

A Study to Evaluate the Drug-drug Interaction Effect of Rifampin on the Pharmacokinetics of AMG 510 in Healthy Participants

Sponsor ID
20190319
Clinicaltrials.gov ID
NCT05577624
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of AMG 510 alone and in combination with rifampin in healthy participants.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
14
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of AMG 510

Timeframe: Days 1, 3 and 8

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510

Timeframe: Days 1, 3 and 8

AUC from Time Zero to Infinity (AUCinf) of AMG 510

Timeframe: Days 1, 3 and 8

Secondary Outcome Measures

Number of Participants with an Adverse Event (AE)

Timeframe: Day 1 to Day 20

Cmax of AMG 510 Metabolite M24

Timeframe: Days 1, 3 and 8

AUClast of AMG 510 Metabolite M24

Timeframe: Days 1, 3 and 8

AUCinf of AMG 510 Metabolite M24

Timeframe: Days 1, 3 and 8

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Covance Clinical Research Unit, Inc 3402 Kinsman Boulevard
Madison, Wisconsin, United States, 53704
Status
Completed
Study Info
Age
18 - 60 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Nov 2019 - Dec 2019
    Inclusion and Exclusion Criteria
    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/m2 (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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.