A Phase 1 interventional study of XG005 and Combination of Naproxen and Pregabalin in Pain, sponsored by Xgene Pharmaceutical Group. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Xgene Pharmaceutical Group · Phase 1, Interventional, and Basic science
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.
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.
Xgene Pharmaceutical Group is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
XG005 capsule in 4 dose level
Drug: XG005
Combination of Naproxen and Pregabalin
Drug: Combination of Naproxen and Pregabalin
XG005 matching placebo
Drug: Placebos
XG005 Capsule
Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica
Placebo Capsule
Maximum concentration (Cmax)
Time frame: Day1 to Day 4
Time to maximum concentration (Tmax)
Time frame: Day1 to Day 4
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Day1 to Day 4
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Day1 to Day 4
Terminal Elimination Rate Constant (kel)
Time frame: Day1 to Day 4
Terminal half-life (t1/2)
Time frame: Day1 to Day 4
Terminal clearance (CL/F)
Time frame: Day1 to Day 4
Volume of distribution (Vd/F)
Time frame: Day1 to Day 4
incidence and severity of adverse events (AEs)
Time frame: Day -1 to Day 8
blood pressure
vital signs
Time frame: Day -1 to Day 8
heart rate
vital signs
Time frame: Day -1 to Day 8
respiratory rate
vital signs
Time frame: Day -1 to Day 8
temperature
vital signs
Time frame: Day -1 to Day 8
physical examination
Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
Time frame: Day -1 to Day 8
electrocardiogram (ECG) parameters;
ECG-PR, RR, QRS, QT, and QTc intervals
Time frame: Day -1 to Day 8
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
Time frame: Day -1 to Day 8
clinical laboratory parameters- hematology
Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
Time frame: Day -1 to Day 8
clinical laboratory parameters urinalysis
* pH • Specific gravity • Protein * Glucose • Ketones • Bilirubin * Blood • Nitrite • Urobilinogen * Leukocytes
Time frame: Day -1 to Day 8
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Xgene Pharmaceutical Group