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

NCT06124144 | Terminated Phase 1 DMC

• 2 other identifiers: TT4CL_EKUT2021-004936-27
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (7)

• Cmax

  21 days

• Tmax

  21 days

• AUC0-t

  21 days

• AUC0-24

  21 days

• AUC0-inf

  21 days

Study Arms (1)

Oleylphosphocholine capsules (IMP) oral administration

EXPERIMENTAL

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

Drug: Oleylphosphocholine

Interventions

Oleylphosphocholine DRUG

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.

Also known as: OlPC

Oleylphosphocholine capsules (IMP) oral administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females of non-childbearing (see below) potential.
• 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.
• Available to participate in follow-up for the duration of trial.
• Living in the area close enough to be able to attend all follow-up visits.
• General good health based on the definition in BreithauptGrögler et al. 2017 and based on history, clinical examination and laboratory results.
• Signed informed consent.
• Consent to provide clinical history and if necessary consent that the study team is allowed to contact the family doctor of the participant.

You may not qualify if:

• 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).
• Mental disorders or other psychiatric conditions (including depression).
• 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.
• Suspected or known injecting drug abuse in the 5 years preceding enrolment.
• Participants unable to be closely followed for social, geographic or psychological reasons.
• Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Institute for Tropical Medicine

Tübingen, 72074, Germany

Location

Related Links

• Official website

MeSH Terms

Conditions

Leishmaniasis

Interventions

oleylphosphocholine

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3 design for ascending doses

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: November 9, 2023
• Study Start: June 21, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-06

Locations

DE (1)