Phase 1 Pharmacokinetics, Safety, and Tolerability Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067947
• Other study ID #: XG005-02
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2019
• Source: Xgene Pharmaceutical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 10, 2020
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy males or females between 18 and 55 years of age

2. BMI 18.0 to 30.0 kg/m2

3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria:

1. Unstable or severe illness

2. History of, or current treatment for, GI disease

3. Clinically significant history of medical condition associated with GI events

4. History of or current glucose intolerance or gestational diabetes

5. Lifetime history of suicidal behavior

6. Creatinine clearance < 90 mL/min

7. Any elevation of liver function tests

8. Creatine kinase (CK) value of greater than 1.5 times the upper limit

9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal

10. Positive Hepatitis B surface antigen, HCV, or HIV

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• XG005
XG005 Tablet
• Placebos
Placebo Tablet

Locations

Country	Name	City	State
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Xgene Pharmaceutical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event related to XG005	Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results	Day 1 to 7 days after last dose