Trials / Completed
CompletedNCT06699628
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
A Single-centre, Open-label, Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Integrative Research Laboratories AB · Industry
- Sex
- All
- Age
- 65 Years – 89 Years
- Healthy volunteers
- Accepted
Summary
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
Detailed description
The trial is open label single oral dose trial in elderly healthy volunteers that will assess the pharmacokinetics of two dose levels of IRL757. Eligible and consenting participants will be included in one of two dose groups, with 6 participants in each dose group. At the screening visit, consenting subjects will be screened for eligibility according to study specific inclusion/exclusion criteria within 4 weeks before Investigational Medicinal Product (IMP) administration. If eligible, participants will be admitted to the phase 1 clinic for the single dose administration of the IMP. All participants will receive active treatment (IRL757). A follow-up visit will be performed for all participants, 5-10 days after IMP administration. Blood and urine sampling will be performed for determination of pharmacokinetic parameters. Safety assessments will also be performed throughout the study: review and collection of adverse events, physical examination, suicidality ideation, electrocardiogram recording, vital signs, safety laboratory assessments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IRL757 | IRL757 capsules |
Timeline
- Start date
- 2024-09-23
- Primary completion
- 2024-11-11
- Completion
- 2024-11-11
- First posted
- 2024-11-21
- Last updated
- 2026-02-05
- Results posted
- 2026-02-05
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06699628. Inclusion in this directory is not an endorsement.