HealthyPhase 1NCT05138796
A Pharmacokinetic Study of TP-05 in Healthy Subjects
A Phase 1 study testing TP-05 (lotilaner oral capsules) in people with Healthy, run by Tarsus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects 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 capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 25 Jul 2022
- 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
- Provision of signed and dated informed consent form (ICF)
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
Who cannot join
- Female who is pregnant or lactating
- Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy)
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- Have a history of a malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
- Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) within 14 days prior to or use of any over-the-counter drugs in the 7 days prior to the first study drug administration
- Positive urine alcohol test result and/or drugs of abuse at Screening or prior to the first drug administration (including cotinine, cannabinoids, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines)
Show all 10Show fewer
- Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
- Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
- Plasma donation within 7 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending-Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
Read the detailed description
This Phase 1 study is a randomized, double-blind, single- and multiple-ascending dose trial to evaluate the safety, tolerability, food-effect, and pharmacokinetics of TP-05 in healthy subjects. Subjects will be enrolled in 5 sequential, ascending single dose cohorts and 3 multiple, ascending dose cohorts. Dose escalation will be approved by a safety monitoring committee before beginning the next cohort. The Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) through Day 15 (in Cohorts 1-5) or through Day 36 (in Cohorts 6-8) occurred in a cohort before proceeding to dosing in the next dose level. In addition, the SRC will review selected PK parameters after selected cohorts. Skin punch biopsies, and venous, capillary, and urine samples may be collected at various timepoints for pharmacokinetic analysis. Safety assessments include monitoring of adverse events, clinical laboratory testing, vital sign measurements, physical examinations, and ECGs. A blood sample may also be collected to evaluate tick mortality upon exposure.
- Conditions
- Healthy
- Being tested
- TP-05 (lotilaner oral capsules), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-05 (lotilaner oral capsules)Drug
TP-05 (lotilaner oral capsules)
PlaceboDrug
Placebo to match TP-05 (lotilaner oral capsules)
| Study group | Role | What they receive |
|---|---|---|
| TP-05 SAD | Experimental | Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order Receives: Drug: TP-05 (lotilaner oral capsules) |
| Placebo SAD | Experimental | Single dose of Placebo Receives: Drug: Placebo |
| TP-05 MAD | Experimental | Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order Receives: Drug: TP-05 (lotilaner oral capsules) |
| Placebo MAD | Experimental | Four doses of Placebo Receives: Drug: Placebo |
| TP-05 Fasted | Experimental | Single dose of TP-05 (lotilaner oral capsules) in a fasted state Receives: Drug: TP-05 (lotilaner oral capsules) |
| Placebo Fasted | Experimental | Single dose of placebo in a fasted state Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Measured: up to 151 days
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 151 days
Clinically significant changes from Baseline hematology laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline hematology laboratory tests
Measured: up to 151 days
Clinically significant changes from Baseline general appearance
Evaluate the safety of TP-05 through clinically significant changes from Baseline general appearance
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of head, ears, nose, and throat
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of head, ears, nose, and throat
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of neck (thyroid)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neck (thyroid)
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of respiratory system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of respiratory system
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of cardiovascular system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of cardiovascular system
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of gastrointestinal system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of gastrointestinal system
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of neurological system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neurological system
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Measured: up to 151 days
Clinically significant changes from Baseline physical examination of skin
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of skin
Measured: up to 151 days
Clinically significant changes from Baseline vital signs
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg])
Measured: up to 151 days
Clinically significant changes from Baseline vital signs (temperature [degrees Celsius])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including temperature [degrees Celsius]
Measured: up to 151 days
Clinically significant changes from Baseline vital signs (pulse rate [beats per minute])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including pulse rate [beats per minute]
Measured: up to 151 days
Clinically significant changes from Baseline vital signs (respiration rate [breaths per minute])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including respiration rate [breaths per minute]
Measured: up to 151 days
Clinically significant changes from Baseline vital signs (systolic and diastolic blood pressure [mmHg])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including changes in systolic and diastolic blood pressure [mmHg])
Measured: up to 151 days
Clinically significant changes from Baseline electrocardiograms (ECGs)
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs (including changes in mean ventricular rate [beats/min], pulse rate [msec], QRS duration [msec], QT interval [msec], QTcF interval [msec])
Measured: up to 151 days
Secondary outcomes (34)
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Cmax at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Tmax at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Tlag at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-168 at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-2880 at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-t at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-inf at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include CL/F at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Vz/F at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include eff at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Thalf at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include λz at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC%extrap at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include MRT0-t at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Rac at various times
Measured: up to 151 days
Exposure and PK of lotilaner in whole blood
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Ctrough at various times
Measured: up to 151 days
Urine exposure and renal PK of lotilaner
PK parameters for urine sampling methods will be evaluated and include Ae.
Measured: 3 days
Urine exposure and renal PK of lotilaner
PK parameters for urine sampling methods will be evaluated and include fe.
Measured: 3 days
Urine exposure and renal PK of lotilaner
PK parameters for urine sampling methods will be evaluated and include CLr0-48.
Measured: 3 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Cmax at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Tmax at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Tlag at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-168 at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-2880 at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-t at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-inf at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include CL/F at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Vz/F at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Thalf at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include λz at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC%extrap at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include MRT0-t at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Rac at various times
Measured: up to 151 days
Impact of fasting on the PK of lotilaner
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Ctrough at various times
Measured: up to 151 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 May 2021
- Primary completion25 Mar 2022
- Study completion25 Jul 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: a randomized, double-blind, single ascending dose (SAD) with Cohort 1-4 administered on a full stomach and Cohort 5 administered after a period of fasting Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation with Cohort 6-8 administered on a full stomach.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Lim, Study director, Tarsus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138796
- Sponsor's protocol ID
- TRS-013
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending-Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05138796
- Acronym / sponsor ID
- TRS-013
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 1 Dec 2021 (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, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
Detailed description
This Phase 1 study is a randomized, double-blind, single- and multiple-ascending dose trial to evaluate the safety, tolerability, food-effect, and pharmacokinetics of TP-05 in healthy subjects. Subjects will be enrolled in 5 sequential, ascending single dose cohorts and 3 multiple, ascending dose cohorts. Dose escalation will be approved by a safety monitoring committee before beginning the next cohort. The Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) through Day 15 (in Cohorts 1-5) or through Day 36 (in Cohorts 6-8) occurred in a cohort before proceeding to dosing in the next dose level. In addition, the SRC will review selected PK parameters after selected cohorts. Skin punch biopsies, and venous, capillary, and urine samples may be collected at various timepoints for pharmacokinetic analysis. Safety assessments include monitoring of adverse events, clinical laboratory testing, vital sign measurements, physical examinations, and ECGs. A blood sample may also be collected to evaluate tick mortality upon exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1: a randomized, double-blind, single ascending dose (SAD) with Cohort 1-4 administered on a full stomach and Cohort 5 administered after a period of fasting Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation with Cohort 6-8 administered on a full stomach.
| Arm | Type | Receives |
|---|---|---|
| TP-05 SAD | Experimental | Drug: TP-05 (lotilaner oral capsules)Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order |
| Placebo SAD | Experimental | Drug: PlaceboSingle dose of Placebo |
| TP-05 MAD | Experimental | Drug: TP-05 (lotilaner oral capsules)Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order |
| Placebo MAD | Experimental | Drug: PlaceboFour doses of Placebo |
| TP-05 Fasted | Experimental | Drug: TP-05 (lotilaner oral capsules)Single dose of TP-05 (lotilaner oral capsules) in a fasted state |
| Placebo Fasted | Experimental | Drug: PlaceboSingle dose of placebo in a fasted state |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of signed and dated informed consent form (ICF)
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
Key exclusion criteria (10 listed)
- Female who is pregnant or lactating
- Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy)
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- Have a history of a malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
- Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) within 14 days prior to or use of any over-the-counter drugs in the 7 days prior to the first study drug administration
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 capsules)TP-05 (lotilaner oral capsules) | Drug | TP-05 Fasted, TP-05 MAD, TP-05 SAD |
| PlaceboPlacebo to match TP-05 (lotilaner oral capsules) | Drug | Placebo Fasted, Placebo MAD, Placebo SAD |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: up to 151 days
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Clinically significant changes from Baseline chemistry laboratory tests
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
Clinically significant changes from Baseline hematology laboratory tests
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline hematology laboratory tests
Clinically significant changes from Baseline general appearance
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline general appearance
Clinically significant changes from Baseline physical examination of head, ears, nose, and throat
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of head, ears, nose, and throat
Clinically significant changes from Baseline physical examination of neck (thyroid)
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neck (thyroid)
Clinically significant changes from Baseline physical examination of respiratory system
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of respiratory system
Clinically significant changes from Baseline physical examination of cardiovascular system
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of cardiovascular system
Clinically significant changes from Baseline physical examination of gastrointestinal system
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of gastrointestinal system
Clinically significant changes from Baseline physical examination of neurological system
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neurological system
Clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Clinically significant changes from Baseline physical examination of skin
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of skin
Clinically significant changes from Baseline vital signs
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg])
Clinically significant changes from Baseline vital signs (temperature [degrees Celsius])
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including temperature [degrees Celsius]
Clinically significant changes from Baseline vital signs (pulse rate [beats per minute])
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including pulse rate [beats per minute]
Clinically significant changes from Baseline vital signs (respiration rate [breaths per minute])
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including respiration rate [breaths per minute]
Clinically significant changes from Baseline vital signs (systolic and diastolic blood pressure [mmHg])
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including changes in systolic and diastolic blood pressure [mmHg])
Clinically significant changes from Baseline electrocardiograms (ECGs)
Time frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs (including changes in mean ventricular rate [beats/min], pulse rate [msec], QRS duration [msec], QT interval [msec], QTcF interval [msec])
34 secondary outcomes
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Exposure and PK of lotilaner in whole blood
Time frame: up to 151 days
Urine exposure and renal PK of lotilaner
Time frame: 3 days
Urine exposure and renal PK of lotilaner
Time frame: 3 days
Urine exposure and renal PK of lotilaner
Time frame: 3 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
Impact of fasting on the PK of lotilaner
Time frame: up to 151 days
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 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Jeremy Lim study director
Tarsus Pharmaceuticals
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 capsules) 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 2 inclusion and 10 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 3 Aug 2022. 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?
Incidence of treatment emergent adverse events (TEAEs) (time frame: up to 151 days). The study lists 18 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 3 Aug 2022.