HealthyPhase 1NCT05720364
Study to Evaluate the Food Effect of TP-05 in Healthy Participants
A Phase 1 study testing TP-05 (lotilaner oral), fasted group, TP-05 (lotilaner oral), high-fat group and TP-05 (lotilaner oral), low-fat group in people with Healthy, run by Tarsus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TP-05 (lotilaner oral), fasted group, TP-05 (lotilaner oral), high-fat group and TP-05 (lotilaner oral), low-fat group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 30 May 2023
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
- Participants who are non- or ex-smokers
- No clinically significant disease captuired in medical history or evidence of clinically significant findings on the physical examination and/or ECG at Screening and Day -1, as determined by the Investigator
- BMI 18.5-29.9 kg/m2 (inclusive) and weighs at least 50.0 kg at Screening
- Ability to comply with contraceptive requirements
Who cannot join
- Female who is breast-feeding or pregnancy according to the serum pregnancy test at Screening and urine pregnancy test at Day -1 prior to study drug administration
- History of significant hypersensitivity to lotilaner or any related products
- History of significant gastrointestinal, metabolic, liver, or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- History of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
- Positive test results for HIV-1/HIV-2 antigen/antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb)
Show all 12Show fewer
- Positive result for SARS-CoV-2 testing at Day -1
- Use of any non-prescription or prescription drugs in the 7 days or 5 half-lives (whichever is longer) prior to study drug administration and through the treatment period of the study
- Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening and through Day 60 of the study
- History of live attenuated vaccine within 4 weeks prior to study drug administration or requirement to receive these vaccinations through Day 60 of the study
- Plasma donation within 7 days prior to Screening through Day 60 of the study
- Blood donation or significant blood loss approximately 500 mL within 56 days prior to Screening through Day 60 of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 Under Fed and Fasted Conditions in Healthy Participants
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.
Read the detailed description
This is a Phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the food effect on the pharmacokinetics of TP-05 under fed and fasted conditions in healthy participants.
The study will consist of a screening period of up to 28 days. Participants who are eligible for the study will check into the clinical research site on Day -1. All participants will undergo an overnight fast of at least 10.5 hours prior to dosing. On Day -1 participants will be randomized to receive one of three treatment regimens on Day 1: single dose of TP-05, fasted; single dose of TP-05 following a high-fat breakfast; or single dose of TP-05 following a low-fat breakfast.
Participants will be resident at the clinical research site from Day -1 until completion of assessments at 96 hours post-dose (Day 5) and return on Day 60 for a follow-up visit. Participants will complete a telephone safety follow-up visit at Day 120.
Safety will be assessed by adverse events, vital signs, performing physical examinations, electrocardiograms, and evaluating clinical laboratory results.
- Conditions
- Healthy
- Being tested
- TP-05 (lotilaner oral), fasted group, TP-05 (lotilaner oral), high-fat group, TP-05 (lotilaner oral), low-fat group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-05 (lotilaner oral), fasted groupDrug
Also called TP-05, fasted
TP-05 (lotilaner oral), fasted group
TP-05 (lotilaner oral), high-fat groupDrug
Also called TP-05, high-fat meal
TP-05 (lotilaner oral), high-fat group
TP-05 (lotilaner oral), low-fat groupDrug
Also called TP-05, low-fat meal
TP-05 (lotilaner oral), low-fat group
| Study group | Role | What they receive |
|---|---|---|
| TP-05, Fasted Group | Experimental | Single dose of TP-05 (lotilaner oral), fasted Receives: Drug: TP-05 (lotilaner oral), fasted group |
| TP-05, High-Fat Group | Experimental | Single dose of TP-05 (lotilaner oral) following a high-fat meal Receives: Drug: TP-05 (lotilaner oral), high-fat group |
| TP-05, Low-Fat Group | Experimental | Single dose of TP-05 (lotilaner oral) following a low-fat meal Receives: Drug: TP-05 (lotilaner oral), low-fat group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of TP-05 in whole blood
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level.
Measured: Up to Day 60
Exposure and PK of lotilaner in whole blood (AUC0-96hours)
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours.
Measured: Up to Day 5
Exposure and PK of lotilaner in whole blood (Cmax)
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax.
Measured: Up to Day 60
Exposure and PK of lotilaner in whole blood (Tmax)
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax.
Measured: Up to Day 60
Exposure and PK of lotilaner in whole blood (Tlag)
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag.
Measured: Up to Day 60
Secondary outcomes (5)
Incidence of treatment emergent adverse events (TEAEs)
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Measured: Up to Day 120
Clinically significant changes from Baseline chemistry laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
Measured: Up to Day 60
Clinically significant changes from Baseline physical examination
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations
Measured: Up to Day 60
Clinically significant changes from Baseline vital signs
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs
Measured: Up to Day 60
Clinically significant changes from Baseline electrocardiograms (ECGs)
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs
Measured: Up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start19 Jan 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Trevejo, MD, PhD, Study director, Tarsus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720364
- Sponsor's protocol ID
- TRS-017
- Status last verified
- Jun 2023
- First submitted
- 31 Jan 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 Under Fed and Fasted Conditions in Healthy Participants
- ClinicalTrials.gov ID
- NCT05720364
- Acronym / sponsor ID
- TRS-017
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 9 Feb 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.
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.
Detailed description
This is a Phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the food effect on the pharmacokinetics of TP-05 under fed and fasted conditions in healthy participants.
The study will consist of a screening period of up to 28 days. Participants who are eligible for the study will check into the clinical research site on Day -1. All participants will undergo an overnight fast of at least 10.5 hours prior to dosing. On Day -1 participants will be randomized to receive one of three treatment regimens on Day 1: single dose of TP-05, fasted; single dose of TP-05 following a high-fat breakfast; or single dose of TP-05 following a low-fat breakfast.
Participants will be resident at the clinical research site from Day -1 until completion of assessments at 96 hours post-dose (Day 5) and return on Day 60 for a follow-up visit. Participants will complete a telephone safety follow-up visit at Day 120.
Safety will be assessed by adverse events, vital signs, performing physical examinations, electrocardiograms, and evaluating clinical laboratory results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP-05, Fasted Group | Experimental | Drug: TP-05 (lotilaner oral), fasted groupSingle dose of TP-05 (lotilaner oral), fasted |
| TP-05, High-Fat Group | Experimental | Drug: TP-05 (lotilaner oral), high-fat groupSingle dose of TP-05 (lotilaner oral) following a high-fat meal |
| TP-05, Low-Fat Group | Experimental | Drug: TP-05 (lotilaner oral), low-fat groupSingle dose of TP-05 (lotilaner oral) following a low-fat meal |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
- Participants who are non- or ex-smokers
- No clinically significant disease captuired in medical history or evidence of clinically significant findings on the physical examination and/or ECG at Screening and Day -1, as determined by the Investigator
- BMI 18.5-29.9 kg/m2 (inclusive) and weighs at least 50.0 kg at Screening
- Ability to comply with contraceptive requirements
Key exclusion criteria (12 listed)
- Female who is breast-feeding or pregnancy according to the serum pregnancy test at Screening and urine pregnancy test at Day -1 prior to study drug administration
- History of significant hypersensitivity to lotilaner or any related products
- History of significant gastrointestinal, metabolic, liver, or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- History of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
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 |
|---|---|---|
| TP-05 (lotilaner oral), fasted groupAlso: TP-05, fastedTP-05 (lotilaner oral), fasted group | Drug | TP-05, Fasted Group |
| TP-05 (lotilaner oral), high-fat groupAlso: TP-05, high-fat mealTP-05 (lotilaner oral), high-fat group | Drug | TP-05, High-Fat Group |
| TP-05 (lotilaner oral), low-fat groupAlso: TP-05, low-fat mealTP-05 (lotilaner oral), low-fat group | Drug | TP-05, Low-Fat Group |
Primary outcome
Concentration of TP-05 in whole blood
Time frame: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level.
Exposure and PK of lotilaner in whole blood (AUC0-96hours)
Time frame: Up to Day 5
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours.
Exposure and PK of lotilaner in whole blood (Cmax)
Time frame: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax.
Exposure and PK of lotilaner in whole blood (Tmax)
Time frame: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax.
Exposure and PK of lotilaner in whole blood (Tlag)
Time frame: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag.
5 secondary outcomes
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to Day 120
Clinically significant changes from Baseline chemistry laboratory tests
Time frame: Up to Day 60
Clinically significant changes from Baseline physical examination
Time frame: Up to Day 60
Clinically significant changes from Baseline vital signs
Time frame: Up to Day 60
Clinically significant changes from Baseline electrocardiograms (ECGs)
Time frame: Up to Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Jose Trevejo, MD, PhD study director
Tarsus Pharmaceuticals, Inc.
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 TP-05 (lotilaner oral), fasted group, TP-05 (lotilaner oral), high-fat group and TP-05 (lotilaner oral), low-fat group in people with Healthy, run by Tarsus Pharmaceuticals, Inc. at 1 site in United States.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 28 Jun 2023. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of TP-05 in whole blood (time frame: Up to Day 60). The study lists 5 primary outcomes in all. 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 28 Jun 2023.