Trials / Completed
CompletedNCT05412472
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Galera Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GC4419 | 45 mg IV infusion of GC4419 over 60 minutes. |
Timeline
- Start date
- 2019-04-04
- Primary completion
- 2021-01-30
- Completion
- 2021-04-06
- First posted
- 2022-06-09
- Last updated
- 2022-06-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05412472. Inclusion in this directory is not an endorsement.