A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
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: Debio 1453P, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. 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
- Belgium
- 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 Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults
Overview
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
Interventions
- Drug Debio 1453P
Powder for oral solution - Drug Placebo
Oral solution
Primary outcome measures
- Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 15 months]
Secondary outcome measures (2)
- Plasma Concentration of Debio 1453P [Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12]
- Urine Concentration of Debio 1453P [Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12]
Eligibility criteria
Inclusion criteria
- Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
- Be within the age range of 18 to 55 years, inclusive, at the time of screening.
- Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2.
Exclusion criteria
- History and/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.
- Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks).
- History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) 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
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- SGS Belgium NV - Clinical Pharmacology Unit — Edegem
Identifiers
NCT: NCT07035769 · Debio 1453-101 · 2024-519328-26 · U1111-1315-2035 · 75A50122C00028 · 224842/Z/21/Z · NNF23SA0088536 · Agreement Dated 1/30/2023 · Agreement Dated 2/28/2023