Pharmacokinetics Study of XG005 Capsule

NCT04499209 | Completed Phase 1

• 1 other identifier: XG005-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (8)

• Maximum concentration (Cmax)

  Day1 to Day 4

• Time to maximum concentration (Tmax)

  Day1 to Day 4

• Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)

  Day1 to Day 4

• Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

  Day1 to Day 4

• Terminal Elimination Rate Constant (kel)

  Day1 to Day 4

• Terminal half-life (t1/2)

  Day1 to Day 4

• Terminal clearance (CL/F)

  Day1 to Day 4

• Volume of distribution (Vd/F)

  Day1 to Day 4

Secondary Outcomes (10)

• incidence and severity of adverse events (AEs)

  Day -1 to Day 8

• blood pressure

  Day -1 to Day 8

• heart rate

  Day -1 to Day 8

• respiratory rate

  Day -1 to Day 8

• temperature

  Day -1 to Day 8

Study Arms (3)

Period 1- XG005

EXPERIMENTAL

XG005 capsule in 4 dose level

Drug: XG005

Period 2- Naproxen and Pregabalin

ACTIVE COMPARATOR

Combination of Naproxen and Pregabalin

Drug: Combination of Naproxen and Pregabalin

Period 1- Placebo

PLACEBO COMPARATOR

XG005 matching placebo

Drug: Placebos

Interventions

XG005 DRUG

XG005 Capsule

Period 1- XG005

Combination of Naproxen and Pregabalin DRUG

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

Period 2- Naproxen and Pregabalin

Placebos DRUG

Placebo Capsule

Period 1- Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI range of 18-30 kg/m2
• Medically healthy subjects
• Creatinine clearance ≥ 80 mL/min

You may not qualify if:

• 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

Sponsors & Collaborators

• Xgene Pharmaceutical Group: lead

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Period 1: Participants and investigators were blinded Period 2: Open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 5, 2020
• Study Start: October 16, 2017
• Primary Completion: January 18, 2018
• Study Completion: March 19, 2018
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)