Healthy VolunteerPhase 1NCT05968612
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
A Phase 1 study testing Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet and Lumacaftor 200 mg Film-Coated Tablet Formulation in people with Healthy Volunteer, run by Qanatpharma Canada LTD at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet and Lumacaftor 200 mg Film-Coated Tablet Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2023to 18 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State.
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.
Read the 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 Lumacaftor 200 mg Film-Coated Tablet test formulation and the commercial product, Lumacaftor 200 mg/Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) under fed conditions, and food-effect bioavailability study of Lumacaftor 200 mg Film-Coated Tablet test formulation from fasted to fed state.
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
- Healthy Volunteer
- Being tested
- Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation
- Keywords
- lumacaftor, cystic fibrosis transmembrane regulator-corrector, CFTR-corrector, food effect, healthy volunteers, cerebral blood flow, CBF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated TabletDrug
Film-coated tablet administered orally.
Lumacaftor 200 mg Film-Coated Tablet FormulationDrug
Film-coated tablet administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Test-Fed) | Experimental | 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. Receives: Drug: Lumacaftor 200 mg Film-Coated Tablet Formulation |
| Treatment B (Reference-Fed) | Active comparator | 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®) Receives: Drug: Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet |
| Treatment C (Test-Fasted) | Experimental | Following a 10-hour overnight fasting period, subjects will receive a single dose of 2 Lumacaftor 200 mg Film-Coated Tablets. Receives: Drug: Lumacaftor 200 mg Film-Coated Tablet Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximal observed plasma concentration (Cmax)
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Measured: Up to 72 hours post dose in each treatment period
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Measured: Up to 72 hours post dose in each treatment period
Area under the concentration-time curve from time zero to infinity (AUCinf)
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Measured: Up to 72 hours post dose in each treatment period
Time when the maximal plasma concentration is observed (Tmax)
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Measured: Up to 72 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Nov 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qanatpharma Canada LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabella Szeto, MD, CCFP, Principal investigator, BioPharma Service Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968612
- Sponsor's protocol ID
- QP586-01
- Status last verified
- Dec 2023
- First submitted
- 21 Jul 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qanatpharma will provide access upon request to individual de-identified participant data reported in the publication beginning 12 months after publication and for up to 36 months following article publication. Data sharing requests can be made by qualified researchers for approved proposals under the terms of a Data Use Agreement. Contact information will be provided at the time of article publication.
Publications
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.
PubMed 40551045
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State.
- ClinicalTrials.gov ID
- NCT05968612
- Acronym / sponsor ID
- QP586-01
- Conditions
- Healthy Volunteer
- Keywords
- lumacaftor, cystic fibrosis transmembrane regulator-corrector, CFTR-corrector, food effect, healthy volunteers, cerebral blood flow, CBF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Qanatpharma Canada LTDIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Lumacaftor 200 mg Film-Coated Tablet test formulation and the commercial product, Lumacaftor 200 mg/Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) under fed conditions, and food-effect bioavailability study of Lumacaftor 200 mg Film-Coated Tablet test formulation from fasted to fed state.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Test-Fed) | Experimental | Drug: Lumacaftor 200 mg Film-Coated Tablet FormulationFollowing 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. |
| Treatment B (Reference-Fed) | Active comparator | Drug: Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated TabletFollowing 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®) |
| Treatment C (Test-Fasted) | Experimental | Drug: Lumacaftor 200 mg Film-Coated Tablet FormulationFollowing a 10-hour overnight fasting period, subjects will receive a single dose of 2 Lumacaftor 200 mg Film-Coated Tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated TabletFilm-coated tablet administered orally. | Drug | Treatment B (Reference-Fed) |
| Lumacaftor 200 mg Film-Coated Tablet FormulationFilm-coated tablet administered orally. | Drug | Treatment A (Test-Fed), Treatment C (Test-Fasted) |
Primary outcome
The maximal observed plasma concentration (Cmax)
Time frame: Up to 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Time frame: Up to 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Time when the maximal plasma concentration is observed (Tmax)
Time frame: Up to 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected pre-dose at 0, and post-dose at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 40551045Papaelias 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.
- Individual participant dataSharing planned: Yes. Qanatpharma will provide access upon request to individual de-identified participant data reported in the publication beginning 12 months after publication and for up to 36 months following article publication. Data sharing requests can be made by qualified researchers for approved proposals under the terms of a Data Use Agreement. Contact information will be provided at the time of article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Szeto, MD, CCFP principal investigator
BioPharma Service Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet and Lumacaftor 200 mg Film-Coated Tablet Formulation in people with Healthy Volunteer, run by Qanatpharma Canada LTD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximal observed plasma concentration (Cmax) (time frame: Up to 72 hours post dose in each treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.