Trials / Completed
CompletedNCT04301804
A Trial of SHR6390 in Healthy Caucasian Volunteers
A Phase I, Randomized, Single Center, Open-Label, Single Dose Pharmacokinetic Study of Reformulated SHR6390 Tablets Under Fasting Conditions in Healthy Caucasian Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Atridia Pty Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers
Detailed description
The objective of this study is to determine the comparative pharmacokinetics, safety and tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting conditions. Each subject will receive a single dose of SHR6390, blood samples will be collected before dosing and at various time points up to 144 hours after drug administration, safety and the statistical analysis of the pharmacokinetic data will be obtained from this study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390 | a selective small-molecule CDK4/6 inhibitor |
Timeline
- Start date
- 2020-03-12
- Primary completion
- 2020-05-28
- Completion
- 2020-09-28
- First posted
- 2020-03-10
- Last updated
- 2022-07-14
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04301804. Inclusion in this directory is not an endorsement.