Status:
COMPLETED
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
Lead Sponsor:
Qanatpharma Canada LTD
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Iv...
Detailed Description
This single-dose, randomized, open-label, three-way crossover, three-period, three-sequence, three-treatment, single-centre, bioequivalence and food-effect study will compare lumacaftor from Lumacafto...
Eligibility Criteria
Inclusion
- Healthy, non-smoking male and non-pregnant female volunteers, 18 years to 55 years of age, inclusive.
- Body mass index (BMI) that is between 18.5 and 30.0 kg/m\^2, inclusive.
- Results of clinical laboratory tests are within the normal range or with a deviation that is not considered clinically significant by the principal investigator.
- Ability to fast for at least 10 hours and consume a high-fat, high-calorie meal, as well as standard meals.
- Agree not to have a tattoo or body piercing until the end of the study.
- 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.
- Female subjects of childbearing potential and males who are able to father children must meet the criteria defined in the protocol.
Exclusion
- Known history or presence of any clinically significant diseases or conditions unless determined as not clinically significant by the Investigator.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Investigator.
- Presence of any significant physical or organ abnormality as determined by the Investigator.
- 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.
- 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).
- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, etc.
- 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.
- Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
- Females having used implanted, injected, intravaginal, or intrauterine hormonal contraceptive within 6 months prior to first study drug administration.
- Females taking oral or transdermal hormonal contraceptives within 30 days prior to first study drug administration.
- Use of any enzyme-modifying drugs or products in the previous 30 days before first study drug administration.
- Use of any prescription medication within 14 days prior to first study drug administration (except medically acceptable contraceptive products).
- Use of any over-the-counter medications within 14 days prior to first study drug administration (except for medically acceptable contraceptive products).
- Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Investigator.
- Difficulty with swallowing whole film-coated tablet.
- Women who are pregnant or lactating.
- Have had a tattoo or body piercing within 30 days prior to first study drug administration.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05968612
Start Date
November 17 2023
End Date
December 18 2023
Last Update
December 26 2023
Active Locations (1)
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1
BioPharma Services Inc.
Toronto, Ontario, Canada, M9L3A2