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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - vital signs
Timepoint [2] 0 0
Day -1 to Day 8
Secondary outcome [3] 0 0
heart rate - vital signs
Timepoint [3] 0 0
Day -1 to Day 8
Secondary outcome [4] 0 0
respiratory rate - vital signs
Timepoint [4] 0 0
Day -1 to Day 8
Secondary outcome [5] 0 0
temperature - vital signs
Timepoint [5] 0 0
Day -1 to Day 8
Secondary outcome [6] 0 0
physical examination - Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
Timepoint [6] 0 0
Day -1 to Day 8
Secondary outcome [7] 0 0
electrocardiogram (ECG) parameters; - ECG-PR, RR, QRS, QT, and QTc intervals
Timepoint [7] 0 0
Day -1 to Day 8
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Day -1 to Day 8
Secondary outcome [9] 0 0
clinical laboratory parameters- hematology - Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
Timepoint [9] 0 0
Day -1 to Day 8
Secondary outcome [10] 0 0
clinical laboratory parameters urinalysis - pH • Specific gravity • Protein
Glucose • Ketones • Bilirubin
Blood • Nitrite • Urobilinogen
Leukocytes
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 Pty Ltd
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/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

Summary results
Other publications