Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
NCT ID: NCT05968612
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2023-11-17
2023-12-18
Brief Summary
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Detailed Description
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The products will be studied using a crossover design with 39 healthy, non-smoking male and non-pregnant female volunteers being administered an oral dose of 1 x (2 x lumacaftor 200 mg) under fasted and fed conditions and 1 x (2 x lumacaftor 200 mg/ ivacaftor 125 mg) under fed conditions. There will be at least a 14-day washout period between the study periods to avoid carry-over effects of the preceding treatments.
This study is being conducted to support development of a lumacaftor mono-substance treatment for improving cerebral blood flow.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A (Test-Fed)
Following a 10-hour overnight fasting period, subjects will eat a high-fat, high-calorie breakfast, and 30 minutes later subjects will receive a single dose of 2 Lumacaftor 200 mg Film-Coated Tablets.
Lumacaftor 200 mg Film-Coated Tablet Formulation
Film-coated tablet administered orally.
Treatment B (Reference-Fed)
Following a 10-hour overnight fasting period, subjects will eat a high-fat, high-calorie breakfast, and 30 minutes later subjects will receive a single dose of 2 Lumacaftor 200 mg/Ivacaftor 125 mg Combination Film-Coated Tablets (Orkambi®)
Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet
Film-coated tablet administered orally.
Treatment C (Test-Fasted)
Following a 10-hour overnight fasting period, subjects will receive a single dose of 2 Lumacaftor 200 mg Film-Coated Tablets.
Lumacaftor 200 mg Film-Coated Tablet Formulation
Film-coated tablet administered orally.
Interventions
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Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet
Film-coated tablet administered orally.
Lumacaftor 200 mg Film-Coated Tablet Formulation
Film-coated tablet administered orally.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) that is between 18.5 and 30.0 kg/m\^2, inclusive.
3. Results of clinical laboratory tests are within the normal range or with a deviation that is not considered clinically significant by the principal investigator.
4. Ability to fast for at least 10 hours and consume a high-fat, high-calorie meal, as well as standard meals.
5. Agree not to have a tattoo or body piercing until the end of the study.
6. Agree not to receive the COVID-19 vaccination from 7 days prior to the first study drug dose until 7 days after the last study drug administration in the study.
7. Female subjects of childbearing potential and males who are able to father children must meet the criteria defined in the protocol.
Exclusion Criteria
2. Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Investigator.
3. Presence of any significant physical or organ abnormality as determined by the Investigator.
4. A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol breath test and cotinine. Positive pregnancy test for female subjects.
5. Known history or presence of:
* Alcohol abuse or dependence within one year prior to first drug administration;
* Drug abuse or dependence;
* Hypersensitivity or idiosyncratic reaction to lumacaftor and ivacaftor, its excipients, and/or related substances;
* Food allergies
* Presence of any dietary restrictions unless deemed by the Investigator as "Not Clinically Significant".
* Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
6. Intolerance to and/or difficulty with blood sampling through venipuncture.
7. Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, etc.
8. Individuals who have donated, in the days prior to first study drug administration:
* 50-499 mL of blood in the previous 30 days;
* 500 mL or more in the previous 56 days.
9. Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
10. Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
11. Females having used implanted, injected, intravaginal, or intrauterine hormonal contraceptive within 6 months prior to first study drug administration.
12. Females taking oral or transdermal hormonal contraceptives within 30 days prior to first study drug administration.
13. Use of any enzyme-modifying drugs or products in the previous 30 days before first study drug administration.
14. Use of any prescription medication within 14 days prior to first study drug administration (except medically acceptable contraceptive products).
15. Use of any over-the-counter medications within 14 days prior to first study drug administration (except for medically acceptable contraceptive products).
16. Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
17. Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing.
18. Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Investigator.
19. Difficulty with swallowing whole film-coated tablet.
20. Women who are pregnant or lactating.
21. Have had a tattoo or body piercing within 30 days prior to first study drug administration.
18 Years
55 Years
ALL
Yes
Sponsors
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Qanatpharma Canada LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Isabella Szeto, MD, CCFP
Role: PRINCIPAL_INVESTIGATOR
BioPharma Service Inc.
Locations
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BioPharma Services Inc.
Toronto, Ontario, Canada
Countries
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References
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Papaelias A, Lidington D, Bolz SS. Demonstrating Bioequivalence for a Lumacaftor Monosubstance Formulation Versus Orkambi(R) (Lumacaftor/Ivacaftor) in Healthy Subjects. Drugs R D. 2025 Sep;25(3):221-229. doi: 10.1007/s40268-025-00514-9. Epub 2025 Jun 23.
Other Identifiers
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QP586-01
Identifier Type: -
Identifier Source: org_study_id