LeishmaniasisPhase 1NCT06124144
Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults
A Phase 1 study testing Oleylphosphocholine in people with Leishmaniasis, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- Oleylphosphocholine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jun 2023to 27 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Leishmaniasis
- Being tested
- Oleylphosphocholine
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OleylphosphocholineDrug
Also called OlPC
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.
| Study group | Role | What they receive |
|---|---|---|
| Oleylphosphocholine capsules (IMP) oral administration | Experimental | Participants will receive once Oleylphosphocholine (capsule/s) orally as a single dose under fed conditions. Receives: Drug: Oleylphosphocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of treatment-emergent adverse events at administration and follow-up visits
Measured: 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
Maximum observed concentration in plasma after single dose (µg/mL)
Measured: 21 days
Tmax
Time of maximum observed concentration (h)
Measured: 21 days
AUC0-t
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)
Measured: 21 days
AUC0-24
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)
Measured: 21 days
AUC0-inf
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)
Measured: 21 days
t1/2
Elimination half-life, calculated as ln(2) / λz (h)
Measured: 21 days
AUCres
Residual Area: extrapolated area (single-dose) calculated as AUCres = 100 (AUC(0-inf) - AUC(0-t)) / AUC(0-inf)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start21 Jun 2023
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: The risk-benefit ratio changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 design for ascending doses
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124144
- Sponsor's protocol ID
- TT4CL_EKUT
- Other IDs
- 2021-004936-27
- Status last verified
- Jun 2023
- First submitted
- 31 Aug 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Oleylphosphocholine (OlPC), Administered Orally in Healthy Adults: A Phase 1, Single Center, Open-label, Staggered, Dose-escalation Trial
- ClinicalTrials.gov ID
- NCT06124144
- Acronym / sponsor ID
- TT4CL_EKUT
- Conditions
- Leishmaniasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The risk-benefit ratio changed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 design for ascending doses
| Arm | Type | Receives |
|---|---|---|
| Oleylphosphocholine capsules (IMP) oral administration | Experimental | Drug: OleylphosphocholineParticipants will receive once Oleylphosphocholine (capsule/s) orally as a single dose under fed conditions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy males and females of non-childbearing (see below) potential.
- Females of non-childbearing potential defined as follows:
- Males must agree:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OleylphosphocholineAlso: OlPCThe 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. | Drug | Oleylphosphocholine capsules (IMP) oral administration |
Primary outcome
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.
7 secondary outcomes
Cmax
Time frame: 21 days
Tmax
Time frame: 21 days
AUC0-t
Time frame: 21 days
AUC0-24
Time frame: 21 days
AUC0-inf
Time frame: 21 days
t1/2
Time frame: 21 days
AUCres
Time frame: 21 days
Results and safety
The study was stopped early (reason given: The risk-benefit ratio changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oleylphosphocholine in people with Leishmaniasis, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The risk-benefit ratio changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.