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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04499209




Registration number
NCT04499209
Ethics application status
Date submitted
13/07/2020
Date registered
5/08/2020
Date last updated
18/08/2020

Titles & IDs
Public title
Pharmacokinetics Study of XG005 Capsule
Scientific 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
Secondary ID [1] 0 0
XG005-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XG005
Treatment: Drugs - Combination of Naproxen and Pregabalin
Treatment: Drugs - Placebos

Experimental: Period 1- XG005 - XG005 capsule in 4 dose level

Active Comparator: Period 2- Naproxen and Pregabalin - Combination of Naproxen and Pregabalin

Placebo Comparator: Period 1- Placebo - XG005 matching placebo


Treatment: Drugs: XG005
XG005 Capsule

Treatment: Drugs: Combination of Naproxen and Pregabalin
Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica

Treatment: Drugs: Placebos
Placebo Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum concentration (Cmax)
Timepoint [1] 0 0
Day1 to Day 4
Primary outcome [2] 0 0
Time to maximum concentration (Tmax)
Timepoint [2] 0 0
Day1 to Day 4
Primary outcome [3] 0 0
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Timepoint [3] 0 0
Day1 to Day 4
Primary outcome [4] 0 0
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Timepoint [4] 0 0
Day1 to Day 4
Primary outcome [5] 0 0
Terminal Elimination Rate Constant (kel)
Timepoint [5] 0 0
Day1 to Day 4
Primary outcome [6] 0 0
Terminal half-life (t1/2)
Timepoint [6] 0 0
Day1 to Day 4
Primary outcome [7] 0 0
Terminal clearance (CL/F)
Timepoint [7] 0 0
Day1 to Day 4
Primary outcome [8] 0 0
Volume of distribution (Vd/F)
Timepoint [8] 0 0
Day1 to Day 4
Secondary outcome [1] 0 0
incidence and severity of adverse events (AEs)
Timepoint [1] 0 0
Day -1 to Day 8
Secondary outcome [2] 0 0
blood pressure
Timepoint [2] 0 0
Day -1 to Day 8
Secondary outcome [3] 0 0
heart rate
Timepoint [3] 0 0
Day -1 to Day 8
Secondary outcome [4] 0 0
respiratory rate
Timepoint [4] 0 0
Day -1 to Day 8
Secondary outcome [5] 0 0
temperature
Timepoint [5] 0 0
Day -1 to Day 8
Secondary outcome [6] 0 0
physical examination
Timepoint [6] 0 0
Day -1 to Day 8
Secondary outcome [7] 0 0
electrocardiogram (ECG) parameters;
Timepoint [7] 0 0
Day -1 to Day 8
Secondary outcome [8] 0 0
clinical laboratory parameters -chemistry
Timepoint [8] 0 0
Day -1 to Day 8
Secondary outcome [9] 0 0
clinical laboratory parameters- hematology
Timepoint [9] 0 0
Day -1 to Day 8
Secondary outcome [10] 0 0
clinical laboratory parameters urinalysis
Timepoint [10] 0 0
Day -1 to Day 8

Eligibility
Key inclusion criteria
- BMI range of 18-30 kg/m2

- Medically healthy subjects

- Creatinine clearance = 80 mL/min
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2018
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xgene Pharmaceutical Group
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04499209
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries