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

University Hospital Tuebingen1 site in 1 country13 target enrollmentJune 21, 2023

ConditionsLeishmaniasis

InterventionsOleylphosphocholine

DrugsOleylphosphocholine

Overview

Phase: Phase 1
Intervention: Oleylphosphocholine
Conditions: Leishmaniasis
Sponsor: University Hospital Tuebingen
Enrollment: 13
Locations: 1
Primary Endpoint: Subject incidence of treatment-emergent adverse events at administration and follow-up visits
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 21, 2023

End Date

February 27, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital Tuebingen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males and females of non-childbearing (see below) potential.
•18 - 60 years of age.
•BMI between 20-30 and body weight from 55-100 kg.
•Females of non-childbearing potential defined as follows:
•Surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or
•Postmenopausal, defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause. A follicle-stimulating hormone (FSH) level will be measured to confirm postmenopausal status.
•Males must agree:
•to use a latex condom during any sexual contact with while participating in the study and for 3 months following discontinuation from this study, even if he has undergone a successful vasectomy.
•to refrain from donating semen or sperm during study participation and for 3 months after discontinuation from this study.
•Able and willing (in the investigator's opinion) to comply with all trial requirements.

Exclusion Criteria

•Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic immunosuppressant medication (more than 14 days) within the past 6 months.
•Any history of or signs of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic clinical significant abnormalities.
•History of chronic infections (e.g., hepatitis В or С) and chronic inflammation.
•History of significant, acute or chronic gastrointestinal, hepatic, cardiac or renal disorders.
•History of leishmaniasis.
•History of hypersensitivity to the excipients present in the investigational medicinal product or to any drug with similar chemical structure (Miltefosine).
•Use of immunoglobulins or blood products within 3 months prior to enrolment.
•Receipt of any investigational medicinal product in the 30 days preceding enrolment, or planned receipt during the trial period.
•Participation in other clinical trials or observation period of competing trials.
•History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ in the last five years).

Arms & Interventions

Oleylphosphocholine capsules (IMP) oral administration

Participants will receive once Oleylphosphocholine (capsule/s) orally as a single dose under fed conditions.

Intervention: Oleylphosphocholine

Outcomes

Primary Outcomes

Subject incidence of treatment-emergent adverse events at administration and follow-up visits

Time Frame: Participants are followed up for 21 days and an additional telephone visit 35 days after drug administration will be conducted before dismissing the participant.