Clinical trial NCT04499209: Pharmacokinetics Study of XG005 Capsule
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Xgene Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Day1 to Day 4
measure: Time to maximum concentration (Tmax)
timeFrame: Day1 to Day 4
measure: Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
timeFrame: Day1 to Day 4
measure: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
timeFrame: Day1 to Day 4
measure: Terminal Elimination Rate Constant (kel)
timeFrame: Day1 to Day 4
measure: Terminal half-life (t1/2)
timeFrame: Day1 to Day 4
measure: Terminal clearance (CL/F)
timeFrame: Day1 to Day 4
measure: Volume of distribution (Vd/F)
timeFrame: Day1 to Day 4
Secondary outcomes:
measure: incidence and severity of adverse events (AEs)
timeFrame: Day -1 to Day 8
measure: blood pressure
timeFrame: Day -1 to Day 8
measure: heart rate
timeFrame: Day -1 to Day 8
measure: respiratory rate
timeFrame: Day -1 to Day 8
measure: temperature
timeFrame: Day -1 to Day 8
measure: physical examination
timeFrame: Day -1 to Day 8
measure: electrocardiogram (ECG) parameters;
timeFrame: Day -1 to Day 8
measure: clinical laboratory parameters -chemistry
timeFrame: Day -1 to Day 8
measure: clinical laboratory parameters- hematology
timeFrame: Day -1 to Day 8
measure: clinical laboratory parameters urinalysis
timeFrame: Day -1 to Day 8
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
References: