A Pharmacokinetic Study of TP-05 in Healthy Subjects

NCT05138796 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TRS-013
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (18)

• Incidence of treatment emergent adverse events (TEAEs)

  Evaluate the safety of TP-05 through the incidence rate of TEAEs

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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)

  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

  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 \[mmHg\])

  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 \[degrees Celsius\]

  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 \[beats per minute\]

  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 \[breaths per minute\]

  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 \[mmHg\])

  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 \[msec\])

  up to 151 days

Secondary Outcomes (34)

• Exposure and PK of lotilaner in whole blood

  up to 151 days

• Exposure and PK of lotilaner in whole blood

  up to 151 days

• Exposure and PK of lotilaner in whole blood

  up to 151 days

• Exposure and PK of lotilaner in whole blood

  up to 151 days

• Exposure and PK of lotilaner in whole blood

  up to 151 days

Study Arms (6)

TP-05 SAD

EXPERIMENTAL

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

Drug: TP-05 (lotilaner oral capsules)

Placebo SAD

EXPERIMENTAL

Single dose of Placebo

Drug: Placebo

TP-05 MAD

EXPERIMENTAL

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

Drug: TP-05 (lotilaner oral capsules)

Placebo MAD

EXPERIMENTAL

Four doses of Placebo

Drug: Placebo

TP-05 Fasted

EXPERIMENTAL

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

Drug: TP-05 (lotilaner oral capsules)

Placebo Fasted

EXPERIMENTAL

Single dose of placebo in a fasted state

Drug: Placebo

Interventions

TP-05 (lotilaner oral capsules) DRUG

TP-05 (lotilaner oral capsules)

TP-05 Fasted; TP-05 MAD; TP-05 SAD

Placebo DRUG

Placebo to match TP-05 (lotilaner oral capsules)

Placebo Fasted; Placebo MAD; Placebo SAD

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (1)

Altasciences

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

lotilaner

Study Officials

• Jeremy Lim

  Tarsus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators, study coordinators, study subjects, and the sponsor will be blinded to treatment assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: December 1, 2021
• Study Start: May 6, 2021
• Primary Completion: March 25, 2022
• Study Completion: July 25, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)