Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets (NCT05968612) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
Canada39 participantsStarted 2023-11-17
Plain-language 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 /Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) in the fed state, and food-effect bioavailability of Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) in the fasted and fed state in healthy, non-smoking, male and non-pregnant female volunteers, 18 to 55 years of age, inclusive.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The maximal observed plasma concentration (Cmax)
Timeframe: Up to 72 hours post dose in each treatment period
2
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Timeframe: Up to 72 hours post dose in each treatment period
3
Area under the concentration-time curve from time zero to infinity (AUCinf)
Timeframe: Up to 72 hours post dose in each treatment period
4
Time when the maximal plasma concentration is observed (Tmax)
Timeframe: Up to 72 hours post dose in each treatment period
. Female subjects of childbearing potential and males who are able to father children must meet the criteria defined in the protocol.
Exclusion criteria
. 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:
. 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: