An interventional study to evaluate the effects of dosages on the Pharmacokinetics (PK, the measure of how the human body processes a substance), Tolerability (how well a substance is tolerated by participants), and Safety of different dosages of XG005 when given to healthy participants as either a single oral dose, or as multiple oral doses.

Phase 1

Completed

• Conditions: Analgesia; Anaesthesiology - Pain management

• Registration Number: ACTRN12619001131145
• Lead Sponsor: Xgene Pharmaceutical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-13
• Study Completion: 2019-11-14
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Healthy males or females between 18 and 55 years of age (at the time of informed consent), inclusive;
2. Body Mass Index (BMI) 18.0 to 30.0 kg/m2, inclusive;
3. Medically healthy, with no clinically significant screening results, in the opinion of the Investigator;
4. Provide signed informed consent on Institutional Review Board (IRB)-approved consent form prior to any study procedures and can understand and comply with the requirements of the study;
5. Non-pregnant, non-breastfeeding female subjects may be enrolled if they are:
a. Documented to be surgically sterile (verbal confirmation acceptable) or postmenopausal (amenorrhea > 1 year and follicle-stimulating hormone greater than or equal to 30 mU/mL); or
b. Practicing true abstinence from at least 28 days prior to Day 1 and willing to continue until 3 months following the last dose of study drug, and must have a negative serum pregnancy test (women of child-bearing potential [WOCBP] only) at screening and a negative urine pregnancy test (WOCBP only) on Day -1 ; or
c. Practicing an effective method of contraception during treatment and for 3 months following the last dose of study drug and having a negative serum pregnancy test (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. Practicing true abstinence for at least 28 days prior to Day 1 and willing to continue until 3 months following the last XG005 dose; or
b. Surgically sterilized (vasectomy– verbal confirmation acceptable), or
c. Willing to use a condom during sexual activity throughout the study and for 3 months after last dose of XG005, plus appropriate contraceptive measures for your female partner . This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential; and
d. Willing to not donate sperm for 3 months after last dose of XG005 (non-vasectomized subjects).
7. Agree to frequent blood and urine sampling during the course of the study;
8. Agree to be confined in the study unit and follow study procedures;
9. Agree to comply with study-specified diet while confined in the Phase 1 unit.

Exclusion Criteria

1. Subjects with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), hematological, or psychiatric system 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 reported history of, or current treatment for, gastrointestinal (GI) disease such as diverticulitis, diverticulosis, irritable bowel syndrome, ulcer, inflammatory bowel disease, upper GI disorders (such as UGID, dyspepsia, heartburn), reflux esophagitis (GERD), or history of conditions such as abdominal gunshot wounds;
3. Subjects with a clinically significant history of medical condition (in the opinion of the Investigator) associated with GI events such as nausea, vomiting, constipation, and diarrhea;
4. Subjects with a history of seizures other than febrile seizures as a child;
5. Subjects with any report of acute illness or febrile event that has not resolved within 72 hours of dosing;
6. Subjects with history of, or current glucose intolerance; or with history of gestational diabetes;
7. Subjects with lifetime history of suicidal behavior or with lifetime history of suicidal ideation as indicated by the C-SSRS (non-suicidal depression will not be exclusionary) (Part 2);
8. Subjects with any use of or intent to use any medications, including prescription, over-the-counter, herbal preparations, or vitamin/mineral supplementation, other than study medications, from 7 days prior to first dose through follow-up visit (except for contraceptives as described in inclusion 5c and occasional paracetamol use, up to 1 g/day, prior to Day -1);
9. Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration, or subjects who are taking drugs known to affect liver, renal, or hematological function in the opinion of the Sponsor or Investigator;
10. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 30 days or 5 half-lives, whichever is longer, prior to first dose;
11. Subjects with creatinine clearance < 90 mL/min (estimated using the Cockcroft and Gault equation);
12. Subjects with any elevation of liver function tests (ALT, AST, GGT, bilirubin, or alkaline phosphatase greater than 1.5 times the upper limit of normal range) at screening; isolated elevation of bilirubin without elevation of direct bilirubin is acceptable;
13. Subjects with a creatine kinase (CK) value of greater than 1.5 times the upper limit of normal (not clinically significant [NCS] abnormality is acceptable) at screening that is not explainable by exercise and that does not come back to reference range upon retest;
14. Subjects with leucocytes or lymphocytes less than 1.5 times the lower limit of normal, eosinophils above the upper limit of normal or hemoglobin < 12.0 g/dL at screening;
15. Subjects with proteinuria (more than trace) at Screening;
16. Female subjects with a positive pregnancy test at screening or Day -1, or who are breastfeeding;
17. Subjects with positive Hepatitis B surface antigen, (except due to recent Hepatitis B vaccination), HCV, or HIV;
18. Male subjects with a resting QTcB or QTcF value < 320 msec or > 450 msec, and female subjects with a resting QTcB or QTcF value < 320 msec or > 4

Study & Design

• Study Type: Interventional
• Study Design: Not specified