Status:
COMPLETED
Phase 1 Pharmacokinetics, Safety, and Tolerability Study
Lead Sponsor:
Xgene Pharmaceutical Group
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.
Detailed Description
This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The ...
Eligibility Criteria
Inclusion
- Healthy males or females between 18 and 55 years of age
- BMI 18.0 to 30.0 kg/m2
- Non-pregnant, non-breastfeeding female subjects
Exclusion
- Unstable or severe illness
- History of, or current treatment for, GI disease
- Clinically significant history of medical condition associated with GI events
- History of or current glucose intolerance or gestational diabetes
- Lifetime history of suicidal behavior
- Creatinine clearance \< 90 mL/min
- Any elevation of liver function tests
- Creatine kinase (CK) value of greater than 1.5 times the upper limit
- Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
- Positive Hepatitis B surface antigen, HCV, or HIV
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04067947
Start Date
July 8 2019
End Date
February 10 2020
Last Update
February 20 2020
Active Locations (1)
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1
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009