Recruiting NCT07678463
A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QX-4533, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Three-part, Phase 1, Single and Multiple Ascending Dose Escalation and Food Effect Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of QX-4533
Overview
The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
Detailed description
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort.
Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation.
Part 3: An open-label, 2-period crossover FE assessment.
Interventions
- Drug QX-4533
QX-4533 tablets - Drug Placebo
QX-4533 matched-placebo tablets
Primary outcome measures
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])]
- Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters [Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])]
Secondary outcome measures (8)
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Time of the Maximum Measured Concentration (Tmax) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Apparent Volume of Distribution at Steady State (Vz/F) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Apparent Clearance (CL/F) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Terminal Elimination Half-Life (t½el) [Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)]
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings [Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])]
Eligibility criteria
Inclusion criteria
- Male or female between 18 and 55 years of age (inclusive) at screening.
- Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Willing and able to comply with this protocol and be available for the entire duration of the study.
- In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at screening and Day -1.
- Has body mass index of 18 to 32 kilograms per meter square (kg/m\^2) inclusive.
Exclusion criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease according to the Investigator.
- History of any Gastrointestinal (GI) procedures (e.g., bariatric surgery) that could impair gastrointestinal absorption.
- History of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant.
- Clinically significant abnormalities on pre-study clinical examination or laboratory safety tests. Laboratory safety assessments (e.g., serum chemistry, hematology, coagulation) will be performed at screening and on Day -1 (if screening is prior to Day -1) to confirm eligibility.
- Treatment with a live (attenuated) vaccine within 8 weeks before the screening visit.
- Positive hepatitis B surface antigen, human immunodeficiency virus antibody, or hepatitis C antibody at the screening visit.
- Use of any prescription within 14 days prior to study treatment administration or use of any over-the-counter medications including food supplements and herbal medications (e.g., St. John's wort), except for contraceptive medications and as needed (pro re nata) paracetamol (not exceeding 2 g/day) within 7 days prior to study treatment administration.
- Participant has participated in another clinical study within the last 4 weeks or within 5 half-lives of the prior study drug, whichever is longer.
- Participants that currently use (including "recreational use") any illicit drugs or have a history of drug abuse in the last 2 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Australia · 1 center
- Nucleus Network Brisbane (Q-pharm) — Brisbane
Identifiers
NCT: NCT07678463 · QX4533-001