A Pharmacokinetic Study of TP-05 in Healthy Subjects

NCT ID: NCT05138796

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-07-25

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

TP-05 SAD

Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order

Group Type: EXPERIMENTAL

TP-05 (lotilaner oral capsules)

Intervention Type: DRUG

TP-05 (lotilaner oral capsules)

Placebo SAD

Single dose of Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to match TP-05 (lotilaner oral capsules)

TP-05 MAD

Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order

Group Type: EXPERIMENTAL

TP-05 (lotilaner oral capsules)

Intervention Type: DRUG

TP-05 (lotilaner oral capsules)

Placebo MAD

Four doses of Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to match TP-05 (lotilaner oral capsules)

TP-05 Fasted

Single dose of TP-05 (lotilaner oral capsules) in a fasted state

Group Type: EXPERIMENTAL

TP-05 (lotilaner oral capsules)

Intervention Type: DRUG

TP-05 (lotilaner oral capsules)

Placebo Fasted

Single dose of placebo in a fasted state

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to match TP-05 (lotilaner oral capsules)

Interventions

TP-05 (lotilaner oral capsules)

TP-05 (lotilaner oral capsules)

Intervention Type: DRUG

Placebo

Placebo to match TP-05 (lotilaner oral capsules)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tarsus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Lim

Role: STUDY_DIRECTOR

Tarsus Pharmaceuticals

Locations

Altasciences

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

TRS-013

Identifier Type: -

Identifier Source: org_study_id