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

University Hospital Tuebingen

Status and phase: Terminated; Phase 1

Conditions: Leishmaniasis

Treatments: Drug: Oleylphosphocholine

Study type: Interventional

Funder types: Other

Identifiers

NCT06124144

TT4CL_EKUT

2021-004936-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females of non-childbearing (see below) potential.

   1. 18 - 60 years of age.
   2. BMI between 20-30 and body weight from 55-100 kg.

2. Females of non-childbearing potential defined as follows:

   1. Surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or
   2. 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.

3. Males must agree:

   1. 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.
   2. to refrain from donating semen or sperm during study participation and for 3 months after discontinuation from this study.

4. Able and willing (in the investigator's opinion) to comply with all trial requirements.

5. Available to participate in follow-up for the duration of trial.

6. Living in the area close enough to be able to attend all follow-up visits.

7. General good health based on the definition in BreithauptGrögler et al. 2017 and based on history, clinical examination and laboratory results.

8. Signed informed consent.

9. Consent to provide clinical history and if necessary consent that the study team is allowed to contact the family doctor of the participant.

10. All subjects are forbidden from donating blood while on study drug and for 3 months after discontinuation from this study

Exclusion criteria

1. 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.
2. Any history of or signs of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic clinical significant abnormalities.
3. History of chronic infections (e.g., hepatitis В or С) and chronic inflammation.
4. History of significant, acute or chronic gastrointestinal, hepatic, cardiac or renal disorders.
5. History of leishmaniasis.
6. History of hypersensitivity to the excipients present in the investigational medicinal product or to any drug with similar chemical structure (Miltefosine).
7. Use of immunoglobulins or blood products within 3 months prior to enrolment.
8. Receipt of any investigational medicinal product in the 30 days preceding enrolment, or planned receipt during the trial period.
9. Participation in other clinical trials or observation period of competing trials.
10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ in the last five years).
11. Mental disorders or other psychiatric conditions (including depression).
12. The average alcohol intake greater than 24 g pure alcohol per day for men or greater than 12 g pure alcohol per day for women (including history of possible addiction) and alcohol consumption on more than five days a week.
13. Suspected or known injecting drug abuse in the 5 years preceding enrolment.
14. Participants unable to be closely followed for social, geographic or psychological reasons.
15. Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination.
16. History of seizure, except for sporadic childhood febrile convulsions.
17. Sjoegren-Larsson-Syndrome (SLS).
18. Participants who are unwilling to ingest the food provided.
19. Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Oleylphosphocholine capsules (IMP) oral administration

Experimental group

Description:

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

Treatment:

Drug: Oleylphosphocholine