A Pharmacokinetic Study of TP-05 in Healthy Subjects

Tarsus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: TP-05 (lotilaner oral capsules)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05138796

TRS-013

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

67 participants in 6 patient groups

TP-05 SAD

Experimental group

Description:

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

Treatment:

Drug: TP-05 (lotilaner oral capsules)

Placebo SAD

Experimental group

Description:

Single dose of Placebo

Treatment:

Drug: Placebo

TP-05 MAD

Experimental group

Description:

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

Treatment:

Drug: TP-05 (lotilaner oral capsules)

Placebo MAD

Experimental group

Description:

Four doses of Placebo

Treatment:

Drug: Placebo

TP-05 Fasted

Experimental group

Description:

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

Treatment:

Drug: TP-05 (lotilaner oral capsules)

Placebo Fasted

Experimental group

Description:

Single dose of placebo in a fasted state

Treatment:

Drug: Placebo