Healthy volunteers test two inhaled drug versions for better absorption
NCT ID NCT07102316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different versions of an inhaled drug (TPIP) in 42 healthy adults to see how much of the drug gets into the blood. Participants inhaled a single dose of each version on separate days. The results help researchers understand which formulation works better for future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
42 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Female participants who are pregnant, nursing, or planning to become pregnant during the study. * 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. * 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. * Use of drugs that inhibit or induce Cytochrome P2C8 (CYP2C8) within 3 weeks prior to first dose until follow-up visit. * 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. * QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 milliseconds (ms). * 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) * Participant has a platelet count less than lower limit of normal and/or a history of abnormal bleeding or bruising. * 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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USA001
Salt Lake City, Utah, 84124, United States
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