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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
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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
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Secondary ID [1]
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XG005-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Day1 to Day 4
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Primary outcome [2]
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Time to maximum concentration (Tmax)
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Assessment method [2]
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Timepoint [2]
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Day1 to Day 4
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Primary outcome [3]
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Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
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Assessment method [3]
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Timepoint [3]
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Day1 to Day 4
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Primary outcome [4]
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Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
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Assessment method [4]
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Timepoint [4]
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Day1 to Day 4
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Primary outcome [5]
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Terminal Elimination Rate Constant (kel)
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Assessment method [5]
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0
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Timepoint [5]
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Day1 to Day 4
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Primary outcome [6]
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Terminal half-life (t1/2)
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Assessment method [6]
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Timepoint [6]
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Day1 to Day 4
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Primary outcome [7]
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Terminal clearance (CL/F)
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Assessment method [7]
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Timepoint [7]
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Day1 to Day 4
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Primary outcome [8]
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Volume of distribution (Vd/F)
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Assessment method [8]
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Timepoint [8]
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Day1 to Day 4
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Secondary outcome [1]
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incidence and severity of adverse events (AEs)
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Assessment method [1]
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Timepoint [1]
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Day -1 to Day 8
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Secondary outcome [2]
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blood pressure
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Assessment method [2]
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vital signs
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Timepoint [2]
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Day -1 to Day 8
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Secondary outcome [3]
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heart rate
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Assessment method [3]
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vital signs
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Timepoint [3]
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Day -1 to Day 8
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Secondary outcome [4]
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respiratory rate
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Assessment method [4]
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vital signs
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Timepoint [4]
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Day -1 to Day 8
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Secondary outcome [5]
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temperature
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Assessment method [5]
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vital signs
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Timepoint [5]
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Day -1 to Day 8
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Secondary outcome [6]
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physical examination
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Assessment method [6]
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Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
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Timepoint [6]
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Day -1 to Day 8
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Secondary outcome [7]
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electrocardiogram (ECG) parameters;
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Assessment method [7]
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ECG-PR, RR, QRS, QT, and QTc intervals
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Timepoint [7]
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Day -1 to Day 8
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Secondary outcome [8]
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clinical laboratory parameters -chemistry
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Assessment method [8]
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BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium
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Timepoint [8]
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Day -1 to Day 8
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Secondary outcome [9]
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clinical laboratory parameters- hematology
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Assessment method [9]
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Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
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Timepoint [9]
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Day -1 to Day 8
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Secondary outcome [10]
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clinical laboratory parameters urinalysis
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Assessment method [10]
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pH • Specific gravity • Protein
Glucose • Ketones • Bilirubin
Blood • Nitrite • Urobilinogen
Leukocytes
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Timepoint [10]
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Day -1 to Day 8
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Eligibility
Key inclusion criteria
- BMI range of 18-30 kg/m2
- Medically healthy subjects
- Creatinine clearance = 80 mL/min
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/03/2018
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Linear Clinical Research Ltd - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Xgene Pharmaceutical Group
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04499209
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04499209
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