A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation
ConditionCystic Fibrosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorVertex Pharmaceuticals Incorporated
About this trial
The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m²), inclusive
Total body weight of greater than (>) 50 kg
Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
Disqualifiers
History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
Any condition possibly affecting drug absorption
Trial design
Design model
Crossover
Treatments tested in this trial
VX-581
DrugTablet and Suspension for Oral Administration.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Sequence 1Experimental treatment 1 intervention
Group B: Sequence 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of VX-581
Time frame
Period 1 and Period 2: From Day 1 up to Day 212
Area Under the Concentration Versus Time Curve (AUC) of VX-581
Time frame
Period 1 and Period 2: From Day 1 up to Day 21Secondary outcomes
1
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 21)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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