Trials / Completed
CompletedNCT02821624
First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers
First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- G1 Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | G1T38 (CDK 4/6 Inhibitor) | CDK 4/6 Inhibitor |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2016-12-15
- Completion
- 2017-04-04
- First posted
- 2016-07-01
- Last updated
- 2017-06-14
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02821624. Inclusion in this directory is not an endorsement.