- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154447
A Phase 1, First-in-human Study of VX-828
A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-828
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Medical Information
- Phone Number: 617-341-6777
- Email: medicalinfo@vrtx.com
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Recruiting
- Altasciences Clinical Kansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- A total body weight of more 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
Key Exclusion Criteria:
- History of febrile illness or other acute illness within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of different dose levels of VX-828.
|
Suspension for Oral Administration
|
Placebo Comparator: Part A: Placebo
Participants will be randomized to receive placebo matched to VX-828.
|
Suspension for Oral Administration
|
Experimental: Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-828.
The dose levels will be determined based on the data from Part A.
|
Suspension for Oral Administration
|
Placebo Comparator: Part B: Placebo
Participants will be randomized to receive placebo matched to VX-828.
|
Suspension for Oral Administration
|
Experimental: Part C: Drug Drug Interaction
Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828 administration, and concomitant administration of VX-828 and Midazolam. Part C will be an open-label optional cohort. |
Suspension for Oral Administration
Solution for Oral Administration
Syrup for Oral Administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: 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 17)
|
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 17)
|
Part B: 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 28)
|
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 28)
|
Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of Itraconazole
Time Frame: From Day 1 up to Day 34
|
From Day 1 up to Day 34
|
Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of Itraconazole
Time Frame: From Day 1 up to Day 34
|
From Day 1 up to Day 34
|
Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828
Time Frame: From Day 1 up to Day 17
|
From Day 1 up to Day 17
|
Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828
Time Frame: From Day 1 up to Day 17
|
From Day 1 up to Day 17
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma
Time Frame: From Day 1 up to Day 15
|
From Day 1 up to Day 15
|
Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma
Time Frame: From Day 1 up to Day 15
|
From Day 1 up to Day 15
|
Part B: Maximum Observed Concentration (Cmax) of VX-828 at Steady State in Plasma
Time Frame: From Day 1 up to Day 28
|
From Day 1 up to Day 28
|
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-828 at Steady State in Plasma
Time Frame: From Day 1 up to Day 28
|
From Day 1 up to Day 28
|
Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Baseline up to Day 35
|
From Baseline up to Day 35
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Cystic Fibrosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Enzyme Inhibitors
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Midazolam
- Itraconazole
Other Study ID Numbers
- VX23-828-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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