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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours post dose in each treatment period
Awards & highlights

Summary

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

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 2023 Phase 3 trial • 435 Patients • NCT05033080
27%
Infective pulmonary exacerbation of cystic fibrosis
25%
COVID-19
23%
Cough
23%
Nasopharyngitis
13%
Headache
12%
Pyrexia
12%
Oropharyngeal pain
11%
Diarrhoea
10%
Rhinorrhoea
10%
Nasal congestion
9%
Upper respiratory tract infection
9%
Influenza
9%
Viral upper respiratory tract infection
9%
Blood creatine phosphokinase increased
9%
Fatigue
9%
Sputum increased
7%
Alanine aminotransferase increased
7%
Haemoptysis
7%
Sinus congestion
6%
Aspartate aminotransferase increased
6%
Abdominal pain upper
6%
Rash
6%
Productive cough
5%
Back pain
5%
Sinusitis
5%
Arthralgia
5%
Abdominal pain
4%
Nausea
4%
Respiratory tract infection
3%
Abdominal distension
1%
Hyperphosphatasaemia
1%
Mechanical ileus
1%
Cholestasis
1%
Cellulitis
1%
Hypersensitivity
1%
Suicidal ideation
1%
Adenocarcinoma
1%
Cerebrovascular arteriovenous malformation
1%
Distal intestinal obstruction syndrome
1%
Appendicitis
1%
Diverticulitis
1%
Blood alkaline phosphatase increased
1%
Syncope
1%
Depression
1%
Pneumonia
1%
Small intestinal obstruction
1%
Urinary tract infection
1%
Viral myocarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
VNZ/TEZ/D-IVA
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

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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.
~23 spots leftby Jul 2025
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