- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124144
Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults
March 7, 2024 updated by: University Hospital Tuebingen
Safety and Pharmacokinetics of Oleylphosphocholine (OlPC), Administered Orally in Healthy Adults: A Phase 1, Single Center, Open-label, Staggered, Dose-escalation Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meral MD Esen, Medical doctor
- Phone Number: +49 70712982365
- Email: itmpm@med.uni-tuebingen.de
Study Locations
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Tübingen, Germany, 72074
- Institute for Tropical Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
- 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.
- All subjects are forbidden from donating blood while on study drug and for 3 months after discontinuation from this study
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).
- 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.
- History of seizure, except for sporadic childhood febrile convulsions.
- Sjoegren-Larsson-Syndrome (SLS).
- Participants who are unwilling to ingest the food provided.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Oleylphosphocholine capsules (IMP) oral administration
Participants will receive once Oleylphosphocholine (capsule/s) orally as a single dose under fed conditions.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Participants are followed up for 21 days and an additional telephone visit 35 days after drug administration will be conducted before dismissing the participant.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 21 days
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Maximum observed concentration in plasma after single dose (µg/mL)
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21 days
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Tmax
Time Frame: 21 days
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Time of maximum observed concentration (h)
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21 days
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AUC0-t
Time Frame: 21 days
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Area under the curve (AUC) from time 0 to the time of the last measurable concentration, calculated using the Linear Up / Log Down trapezoidal rule (h*µg/mL)
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21 days
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AUC0-24
Time Frame: 21 days
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Area under the curve from time 0 to hour 24 (single-dose only), calculated using the Linear Up / Log Down trapezoidal rule (h*µg/mL)
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21 days
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AUC0-inf
Time Frame: 21 days
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Area under the curve from time 0 to infinity (single-dose only), calculated as AUC0-inf = AUC0-t + Ct / λz, where Ct is the last observed quantifiable concentration and λz is the elimination rate constant (h*µg/mL)
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21 days
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t1/2
Time Frame: 21 days
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Elimination half-life, calculated as ln(2) / λz (h)
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21 days
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AUCres
Time Frame: 21 days
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Residual Area: extrapolated area (single-dose) calculated as AUCres = 100 (AUC(0-inf) - AUC(0-t)) / AUC(0-inf)
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21 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2023
Primary Completion (Actual)
February 27, 2024
Study Completion (Actual)
February 27, 2024
Study Registration Dates
First Submitted
August 31, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 9, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TT4CL_EKUT
- 2021-004936-27 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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