Pharmacokinetics Study of XG005 Capsule

Pain Clinical Trial

Official title:

A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499209
• Other study ID #: XG005-01
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: August 2020
• Source: Xgene Pharmaceutical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.

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 total of 5 ascending dose levels pending safety review, and PK review where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005 and 1 for placebo) were included as the first dose administered at each dose level in Period 1.

In Period 2, all subjects in the last three XG005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout period. Period 2 was open-label with 10 subjects per group.

PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 19, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• BMI range of 18-30 kg/m2

• Medically healthy subjects

• Creatinine clearance = 80 mL/min

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• XG005
XG005 Capsule
• Combination of Naproxen and Pregabalin
Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica
• Placebos
Placebo Capsule

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	Maximum concentration (Cmax)		Day1 to Day 4
Primary	Time to maximum concentration (Tmax)		Day1 to Day 4
Primary	Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)		Day1 to Day 4
Primary	Area under the concentration-time curve from time 0 to infinity (AUC0-inf)		Day1 to Day 4
Primary	Terminal Elimination Rate Constant (kel)		Day1 to Day 4
Primary	Terminal half-life (t1/2)		Day1 to Day 4
Primary	Terminal clearance (CL/F)		Day1 to Day 4
Primary	Volume of distribution (Vd/F)		Day1 to Day 4
Secondary	incidence and severity of adverse events (AEs)		Day -1 to Day 8
Secondary	blood pressure	vital signs	Day -1 to Day 8
Secondary	heart rate	vital signs	Day -1 to Day 8
Secondary	respiratory rate	vital signs	Day -1 to Day 8
Secondary	temperature	vital signs	Day -1 to Day 8
Secondary	physical examination	Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin	Day -1 to Day 8
Secondary	electrocardiogram (ECG) parameters;	ECG-PR, RR, QRS, QT, and QTc intervals	Day -1 to Day 8
Secondary	clinical laboratory parameters -chemistry	BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium	Day -1 to Day 8
Secondary	clinical laboratory parameters- hematology	Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count	Day -1 to Day 8
Secondary	clinical laboratory parameters urinalysis	pH • Specific gravity • Protein; Glucose • Ketones • Bilirubin; Blood • Nitrite • Urobilinogen; Leukocytes	Day -1 to Day 8