Pharmacokinetics Study of XG005 Capsule
- Conditions
- Pain
- Interventions
- Registration Number
- NCT04499209
- Lead Sponsor
- Xgene Pharmaceutical Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- BMI range of 18-30 kg/m2
- Medically healthy subjects
- Creatinine clearance ≥ 80 mL/min
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Period 1- XG005 XG005 XG005 capsule in 4 dose level Period 2- Naproxen and Pregabalin Combination of Naproxen and Pregabalin Combination of Naproxen and Pregabalin Period 1- Placebo Placebos XG005 matching placebo
- Primary Outcome Measures
Name Time Method Terminal clearance (CL/F) Day1 to Day 4 Terminal Elimination Rate Constant (kel) Day1 to Day 4 Maximum concentration (Cmax) Day1 to Day 4 Time to maximum concentration (Tmax) Day1 to Day 4 Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t) Day1 to Day 4 Terminal half-life (t1/2) Day1 to Day 4 Area under the concentration-time curve from time 0 to infinity (AUC0-inf) Day1 to Day 4 Volume of distribution (Vd/F) Day1 to Day 4
- Secondary Outcome Measures
Name Time Method respiratory rate Day -1 to Day 8 vital signs
temperature Day -1 to Day 8 vital signs
physical examination Day -1 to Day 8 Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
electrocardiogram (ECG) parameters; Day -1 to Day 8 ECG-PR, RR, QRS, QT, and QTc intervals
clinical laboratory parameters -chemistry Day -1 to Day 8 BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium
clinical laboratory parameters- hematology Day -1 to Day 8 Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
incidence and severity of adverse events (AEs) Day -1 to Day 8 blood pressure Day -1 to Day 8 vital signs
heart rate Day -1 to Day 8 vital signs
clinical laboratory parameters urinalysis Day -1 to Day 8 * pH • Specific gravity • Protein
* Glucose • Ketones • Bilirubin
* Blood • Nitrite • Urobilinogen
* Leukocytes
Trial Locations
- Locations (1)
Linear Clinical Research Ltd
🇦🇺Nedlands, Western Australia, Australia