A Phase I, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of XG2002 Oral Administration in Healthy Adult Volunteers
- Conditions
- Acute and Chronic PainNeurological - Other neurological disorders
- Registration Number
- ACTRN12624000245594
- Lead Sponsor
- Xgene Pharmaceutical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1. Healthy male or female volunteers between 18 and 65 years of age, inclusive (at the
time of ICF).
2. Weight greater than or equal to 60 kg and a Body Mass Index (BMI) 18.0 to 35.0 kg/m2, inclusive.
3. Medically healthy, with no clinically significant medical conditions in the opinion of the Investigator.
4. Able to comprehend and provide voluntarily signed informed consent form, and to abide by the study restrictions and requirements.
5. Non-pregnant, non-breastfeeding female subjects may be enrolled if they are:
a. Surgically sterilized (verbal confirmation acceptable) or postmenopausal
(amenorrhea greater than or equal to 1 year and follicle-stimulating hormone greater than or equal to 30 mU/mL); or
b. Practicing true abstinence or an effective method of contraception from Screening visit until 3 months following the last dose of study drug, and must have a negative serum pregnancy test (women of childbearing potential [WOCBP] only) at screening and a negative urine pregnancy test (WOCBP only) on Day -1.
6. Male subjects may be enrolled if they are:
a. Surgically sterilized (vasectomy – verbal confirmation acceptable); or
b. Practicing true abstinence from Screening visit until 90 days following the last dose of study drug; or
c. Willing to use a condom during sexual activity, plus appropriate contraceptive measures for his female partner from Screening visit until 90 days after the last dose of study drug. This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential; and
d. Do not donate sperm for 90 days after last dose of study drug (non- vasectomized subjects).
1. Subjects with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), haematological, or psychiatric as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECGs evaluations, or in the opinion of the Investigator.
2. Subjects with clinically significant history of medical condition (in the opinion of the Investigator).
3. Subjects with any report of acute illness or febrile event that has not been resolved within 72 hours prior to dosing.
4. Subjects with any of the following laboratory test results at Screening:
a. creatinine clearance < 90 mL/min (estimated using the Cockcroft and Gault equation)
b. elevation of liver function tests: ALT, AST, GGT, bilirubin, or alkaline phosphatase > 1.5 times of the upper limit of normal range
c. leucocytes or lymphocytes < 1.5 times of the lower limit of normal
d. hemoglobin < the normal range of corresponding gender
5. Subjects with positive results for hepatitis B surface antigen (HbsAg) and/or hepatitis B anticore antibody (anti-HBc) but negative results for anti-surface antibody (antiHBs) at Screening visit
6. Positive results for hepatitis C antibody unless patient received curative therapy and a negative viral load is documented.
7. Human immunodeficiency virus (HIV) infection or positive HIV serology at the Screening Visit.
8. Subjects who have smoked more than 5 tobacco or nicotine-containing product (including nicotine patches) per week for 90 days prior to screening through to the end of the study.
9. Positive urine drug screen at Screening and Day -1, or positive alcohol breath test on Day -1.
10. Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to drug administration, or plan to consume them through the completion of the follow-up visit.
11. Sleep pills 3 days prior to randomization and for the duration of the study
12. Unless a specific dietary need can be catered for at the study site, subjects with an abnormal diet including lactose/gluten intolerance, food rich with capsaicin or causing dysgeusia or other dietary restrictions (except vegetarian/vegan or religious dietary requirements), as determined by the Investigator 30 days prior to the study dosing.
13. Subjects with a history of donation of blood or blood products, or significant blood loss (>480ml) within 30 days prior to the study dosing.
14. Participation in another clinical trial with medicinal intervention within 30 days or 5 half-lived, whichever is longer, prior to the study dose.
15. Known or suspected hypersensitivity or idiosyncratic reaction to the study drug or its excipient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Primary Outcome: To investigate the safety and tolerability of XG2002 following a single oral administration in healthy participants.[Treatment Emergent Adverse Events (TEAEs) including core body temperature measurement. TEAEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and assessed and recorded continuously as they occur from Day 1 post-dose through to Day 4 Exit Visit or Early Termination (EV/ET). <br>Core Body Temperature (CBT) will be measured via an ingested real-time monitoring device. CBT will be monitored in real-time for up to 24 hours post-dose with the device capsule being expelled in faeces naturally.]
- Secondary Outcome Measures
Name Time Method To evaluate systemic pharmacokinetic (PK) following single oral administration of XG2002 in healthy participants. A sub-intolerable dose level may be tested, for example, if 800 mg dose is the intolerable dose, a cohort for 600 mg may be tested.[The following parameters will be calculated: Tmax, Cmax, AUCinf, AUClast, AUCt, Cmax,ss, Cmin,ss, Tmax,ss, accumulation ratio (AR), CL/F, Vd/F and T1/2. Blood plasma samples will be collected pre-dose Day 1, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr , 18 hr and 24 hrs post-dose.]