Study Complete
Sponsor ID
20190321

A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects

Sponsor ID
20190321
Clinicaltrials.gov ID
NCT05578859
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510

and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of [14C]-AMG 510 in healthy male participants.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
8
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)

Timeframe: Day 1 to Day 14

AUC from time zero to the last quantifiable concentration (AUClast)

Timeframe: Day 1 to Day 14

Maximum observed concentration (Cmax)

Timeframe: Day 1 to Day 14

Time of Cmax (tmax)

Timeframe: Day 1 to Day 14

Apparent terminal elimination half-life (t1/2)

Timeframe: Day 1 to Day 14

Total clearance (AMG 510 only; CL/F)

Timeframe: Day 1 to Day 14

Volume of distribution (AMG 510 only; Vz/F)

Timeframe: Day 1 to Day 14

Plasma AMG 510 to total radioactivity ratio

Timeframe: Day 1 to Day 14

Whole blood to plasma total radioactivity ratio

Timeframe: Day 1 to Day 14

Amount (Aeu) of AMG510 excreted in urine

Timeframe: Day 1 to Day 14

Percentage (feu) of AMG510 excreted in urine

Timeframe: Day 1 to Day 14

Renal clearance (CLR) of AMG510

Timeframe: Day 1 to Day 14

Amount (Aef) of AMG510 excreted in feces

Timeframe: Day 1 to Day 14

Percentage (fef) of AMG510 excreted in feces

Timeframe: Day 1 to Day 14

Secondary Outcome Measures

Metabolite profile of AMG 510

Timeframe: Day 1 to Day 14

Identification of AMG 510 metabolites

Timeframe: Day 1 to Day 14

Incidence of adverse events

Timeframe: Up to approximately 6 weeks

QTc interval measured by 12-lead electrocardiogram (ECG)

Timeframe: Up to approximately 6 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit, Inc
Madison, WI, United States, 53704
Status
Completed