A Study to Evaluate the Drug-drug Interaction Effect of Itraconazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of AMG 510 administered alone and in combination with itraconazole in healthy participants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AMG 510 + Itraconazole
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Drug: AMG 510
Oral tablet
Drug: Itraconazole
Oral capsule
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of AMG 510 [Day 1 and Day 6]
- Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510 [Day 1 and Day 6]
- AUC from Time Zero to Infinity (AUCinf) of AMG 510 [Day 1 and Day 6]
Secondary Outcome Measures
- Number of Participants with an Adverse Event (AE) [Day 1 to Day 8]
An adverse event is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.
- Cmax of AMG 510 Metabolite M24 [Day 1 and Day 6]
- AUClast of AMG 510 Metabolite M24 [Day 1 and Day 6]
- AUCinf of AMG 510 Metabolite M24 [Day 1 and Day 6]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
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Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
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Females of nonchildbearing potential
Exclusion Criteria:
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Inability to swallow oral medication or history of malabsorption syndrome.
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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.
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Poor peripheral venous access.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance Clinical Research Unit, Inc | Daytona Beach | Florida | United States | 32117 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20190318