Status:
COMPLETED
Pharmacokinetics Study of XG005 Capsule
Lead Sponsor:
Xgene Pharmaceutical Group
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and th...
Detailed Description
Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005 and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled sequentially into a tot...
Eligibility Criteria
Inclusion
- BMI range of 18-30 kg/m2
- Medically healthy subjects
- Creatinine clearance ≥ 80 mL/min
Exclusion
- History or presence of significant diseases
- History or presence of alcoholism or drug abuse
- Consumption of alcohol 48 hours prior each dose
- Hypersensitivity or idiosyncratic reaction to the study drug
- Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;
- Donation (standard donation amount or more) of blood or blood products
- Plasma donation within 7 days prior to the study;
- Participation in another clinical trial within 30 days prior to the first dose;
- Female subjects who are pregnant or lactating;
- Hemoglobin \< 120 g/L
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04499209
Start Date
October 16 2017
End Date
March 19 2018
Last Update
August 18 2020
Active Locations (1)
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1
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009