A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The primary objective of this study is to determine the relative bioavailability of treprostinil (TRE) between the TPIP F2 and TPIP F3 at 3 capsule strengths, dose A, dose B, and dose C, in healthy participants following a single inhalation of TPIP dose.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- Body mass index (BMI): 18.0 to 32.0 kilogram per square metre (kg/m^2), inclusive, at screening.
- Weight: ≥50 kg (kilograms), inclusive, at screening.
- Must be a nonsmoker (no use of tobacco or nicotine products) and/or has not used chewing tobacco for at least 1 month prior to screening.
- Participants must be able to inhale study treatment using a dry powder inhaler.
- All medication (including over-the-counter medication, health supplements such as St. John's wort extract) must have been stopped at least 14 days prior to clinical site admission. An exception is made for acetaminophen, which is allowed up to admission to the clinical facility. Female participants may continue to use hormonal contraceptives throughout the study.
Exclusion Criteria
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Female participants who are pregnant, nursing, or planning to become pregnant during the study.
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Participant has a positive serology test result for human immunodeficiency virus 1 or 2, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies at screening. A positive result for hepatitis C virus antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
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History of malignancy within 5 years prior to screening, with exception of completely treated in situ carcinoma of the cervix, and completely treated non-metastatic squamous cell or basal cell carcinoma of the skin.
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Use of drugs that inhibit or induce Cytochrome P2C8 (CYP2C8) within 3 weeks prior to first dose until follow-up visit.
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Participant has received any study drug in another investigational study within 30 days of screening or less than 5 times the drug's half-life, whichever is longer.
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QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 milliseconds (ms).
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The participant had active liver disease or hepatic dysfunction at screening or admission, manifested as:
- Elevated liver function test results (Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST] > 2 × Upper Limit of Normal [ULN])
- Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN; ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
- Known hepatic or biliary abnormalities (excluding Gilbert's syndrome or asymptomatic gallstones)
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Participant has a platelet count less than lower limit of normal and/or a history of abnormal bleeding or bruising.
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Participant has a history of alcohol or drug abuse within 3 months before screening or excessive alcohol consumption (i.e., > 21 units/week for males, > 14 units/week for females) (1 unit is equal to approximately 1/2 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
Note: Other protocol defined inclusion/exclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Insmed Medical Information
Data sourced from clinicaltrials.gov
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