A Pharmacokinetic Study of TP-05 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT05138796

Run by

Tarsus Pharmaceuticals, Inc.

People needed

67

Starts

2021-05-06

Expected to finish

2022-07-25

Last updated by the study team

2022-08-03

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Altasciences — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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