Healthy Participants
Conditions
Keywords
Healthy participants, AMG 510, Itraconazole
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.
Interventions
DRUGAMG 510
Oral tablet
DRUGItraconazole
Oral capsule
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects or female subjects, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum Observed Plasma Concentration (Cmax) of AMG 510 | Day 1 and Day 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| AUCinf of AMG 510 Metabolite M24 | Day 1 and Day 6 | — |
| Cmax of AMG 510 Metabolite M24 | Day 1 and Day 6 | — |
| AUClast of AMG 510 Metabolite M24 | Day 1 and Day 6 | — |
Countries
United States
Outcome results
None listed