NCT06124144

Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults

Safety and Pharmacokinetics of Oleylphosphocholine (OlPC), Administered Orally in Healthy Adults: A Phase 1, Single Center, Open-label, Staggered, Dose-escalation Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to assess the safety and tolerability of OlPC and to characterize the pharmacokinetics (PK) of OlPC following single, ascending doses administered orally in healthy-fed subjects.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
DRUG	Oleylphosphocholine	The trial is a dose escalation trial that follows a 3+3 approach. The sample size is determined by a decision-making algorithm and by the tolerability of the study drug in the study participants. This design follows predetermined rules that help identify notable toxicities in time with a reasonable degree of accuracy. The initial dose will be 50mg OlPC (1 capsule) and participants in subsequent cohorts will receive 100mg (2 capsules), 150mg (3 capsules), 200mg (4 capsules), 250mg (5 capsules), or 300mg (6 capsules) if the previous doses are tolerated. The study ends when the last cohort is completed or when it is determined that a dose (within a cohort) is not tolerable.

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2023-11-09
• Last updated: 2024-03-12

Locations

1 site across 1 country: Germany