Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function

Phase 1 Completed 12 enrolled Amgen

Non-randomizedParallel-groupOpen-labelTreatment

Summary

A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.

Timeline

Start: 2017-12-12
Primary completion: 2018-03-12
Completion: 2018-04-05

Publications

Background Trivedi A, Mather O, Vega S, Simiens MA, Hellawell J, Lee E. Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986. Drugs R D. 2022 Mar;22(1):89-94. doi: 10.1007/s40268-021-00380-1. Epub 2022 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG 986	Unknown	200 mg	Oral

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function

Summary

Timeline

Publications

Drugs

Indications