Health TrialsbyHealthPanel

Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose

ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-55
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m²), inclusive

A total body weight of more than (>) 50 kg

Participants must have regular bowel movements (i.e., average of more than or equal to (>=) 1 and less than or equal to (<=)3 stools per day)

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, distribution, metabolism, or excretion

Exposure to any nonenvironmental radiation (e.g., diagnostic medical imaging or occupational exposure) within 12 months before study drug administration

Participation in more than 1 radiolabeled study (if the previous study's radiation exposure is unknown) or participation in more than 3 radiolabeled studies (if the previous studies' radiation exposure is known) in the 12 months before dosing or if the annual whole-body radiation exposure from all previous studies (including this dosing) is more than the FDA-allowed maximum whole body radiation exposure of 5000 mrem

Trial design

Design model

Single group

Treatments tested in this trial

  • 14C-VX-407

    Drug

    Solution for Oral Administration.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: 14C-VX-407Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Amount of Radioactivity Excreted (Ae) of 14C-VX-407 Total Radioactivity (TRA) in Urine, and Feces

Time frame
From Day -1 up to Day 30
2

Terminal Phase Rate Constant (λz) of VX-407 in Plasma

Time frame
From Day 1 up to Day 30
3

Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-407 in Plasma

Time frame
From Day 1 up to Day 30
4

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma

Time frame
From Day 1 up to Day 30

Secondary outcomes

1

Metabolite Profiling and Identification in Plasma, Urine, and Feces

Time frame
From Day 1 up to Day 30
2

Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma

Time frame
From Day 1 up to Day 30
3

AUC0-tlast of VX-407 Metabolites in Plasma

Time frame
From Day 1 up to Day 30
4

AUC0-inf of VX-407 Metabolites in Plasma

Time frame
From Day 1 up to Day 30

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: