Pharmacokinetics Study of XG005 Capsule

NCT ID: NCT04499209

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2018-03-19

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

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 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Period 1- XG005

XG005 capsule in 4 dose level

Group Type: EXPERIMENTAL

XG005

Intervention Type: DRUG

XG005 Capsule

Period 2- Naproxen and Pregabalin

Combination of Naproxen and Pregabalin

Group Type: ACTIVE_COMPARATOR

Combination of Naproxen and Pregabalin

Intervention Type: DRUG

Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica

Period 1- Placebo

XG005 matching placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo Capsule

Interventions

XG005

XG005 Capsule

Intervention Type: DRUG

Combination of Naproxen and Pregabalin

Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica

Intervention Type: DRUG

Placebos

Placebo Capsule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xgene Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

XG005-01

Identifier Type: -

Identifier Source: org_study_id