Clinical trial NCT05138796: A Pharmacokinetic Study of TP-05 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF)
2. 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

Exclusion Criteria:

1. Female who is pregnant or lactating
2. Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy)
3. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
4. Have a history of a malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
5. 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
6. 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)
7. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
8. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening
9. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
10. Plasma donation within 7 days prior to screening

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline chemistry laboratory tests
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline hematology laboratory tests
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline general appearance
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of head, ears, nose, and throat
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of neck (thyroid)
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of respiratory system
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of cardiovascular system
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of gastrointestinal system
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of neurological system
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline physical examination of skin
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline vital signs
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline vital signs (temperature [degrees Celsius])
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline vital signs (pulse rate [beats per minute])
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline vital signs (respiration rate [breaths per minute])
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline vital signs (systolic and diastolic blood pressure [mmHg])
timeFrame: up to 151 days
measure: Clinically significant changes from Baseline electrocardiograms (ECGs)
timeFrame: up to 151 days
Secondary outcomes:
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Exposure and PK of lotilaner in whole blood
timeFrame: up to 151 days
measure: Urine exposure and renal PK of lotilaner
timeFrame: 3 days
measure: Urine exposure and renal PK of lotilaner
timeFrame: 3 days
measure: Urine exposure and renal PK of lotilaner
timeFrame: 3 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
measure: Impact of fasting on the PK of lotilaner
timeFrame: up to 151 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences
state: Kansas
Study officials:
affiliation: Tarsus Pharmaceuticals
name: Jeremy Lim
role: STUDY_DIRECTOR
References: