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Lumacaftor Film-Coated Tablets for Healthy Subjects

Phase 1
Waitlist Available
Led By Isabella Szeto, MD, CCFP
Research Sponsored by Qanatpharma Canada LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to fast for at least 10 hours and consume a high-fat, high-calorie meal, as well as standard meals
Healthy, non-smoking male and non-pregnant female volunteers, 18 years to 55 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours post dose in each treatment period
Awards & highlights

Study Summary

This trial tests if a generic version of a drug combo is as effective as the original, and if food affects its bioavailability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours post dose in each treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours post dose in each treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Area under the concentration-time curve from time zero to infinity (AUCinf)
The maximal observed plasma concentration (Cmax)
+1 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04043806
25%
Cough
23%
Infective pulmonary exacerbation of cystic fibrosis
20%
Headache
16%
Upper respiratory tract infection
15%
Sputum increased
14%
Pyrexia
13%
Oropharyngeal pain
13%
Nasopharyngitis
11%
Nasal congestion
10%
Fatigue
10%
Viral upper respiratory tract infection
9%
Nausea
9%
Immunisation reaction
9%
Alanine aminotransferase increased
9%
Blood creatine phosphokinase increased
9%
Haemoptysis
8%
Rhinorrhoea
7%
Abdominal pain
7%
Diarrhoea
7%
COVID-19
7%
Sinusitis
7%
Aspartate aminotransferase increased
7%
Back pain
6%
Arthralgia
6%
Dyspnoea
6%
Productive cough
6%
Sinus congestion
6%
Rash
5%
Vomiting
5%
Pain
5%
Myalgia
5%
Respiration abnormal
2%
Pneumonia
1%
Distal intestinal obstruction syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: ELX/TEZ/IVA
Part B: ELX/TEZ/IVA

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment C (Test-Fasted)Experimental Treatment1 Intervention
Following a 10-hour overnight fasting period, subjects will receive a single dose of 2 Lumacaftor 200 mg Film-Coated Tablets.
Group II: Treatment A (Test-Fed)Experimental Treatment1 Intervention
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.
Group III: Treatment B (Reference-Fed)Active Control1 Intervention
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®)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumacaftor 200 mg Film-Coated Tablet Formulation
2023
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Qanatpharma Canada LTDLead Sponsor
Isabella Szeto, MD, CCFPPrincipal InvestigatorBioPharma Service Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Treatment A (Test-Fed) been acknowledged by the FDA as safe for use?

"Our team at Power has assessed that Treatment A (Test-Fed) presents a low safety risk, as it is currently in its first clinical trial phase and only preliminary data exists to support both efficacy and security."

Answered by AI

Are there any current opportunities to enroll in this research endeavor?

"As per the information presented on clinicaltrials.gov, this study has been actively recruiting participants since October 1st, 2023 and was recently updated as of October 5th, 2023."

Answered by AI

Does this experiment permit elderly participants?

"This clinical trial only permits those aged between 18 and 55 to join. Meanwhile, there are 65 research studies catered for minors under 18 years old, while 398 trials focus on seniors who exceed the age of 65."

Answered by AI

How many participants are included in the ongoing clinical trial?

"Affirmative. According to information posted on clinicaltrials.gov, this medical experiment is actively enlisting participants since October 1st 2023. As of now, 39 patients need to be gathered from a single location and the trial has been updated recently on October 5th 2023."

Answered by AI

Can I sign up for this medical research program?

"This clinical trial is recruiting 39 participants aged 18 to 55 who are considered healthy. Eligible applicants must not smoke, have a BMI between 18.5 and 30.0 kg/m2, have normal lab results according to the principal investigator's discretion, be able to fast for 10 hours and consume high-fat meals as well as regular food items, agree not to get tattoos or piercings during participation in the study, abstain from receiving Covid-19 vaccinations within 7 days of their first dose until seven days after their last dose administration and if they are either of reproductive age or capable of fathering children meet certain criteria outlined"

Answered by AI
~26 spots leftby Apr 2025