A Phase 1, First-in-human Study of VX-828

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-828

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154447
• Other study ID #: VX23-828-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 12, 2023
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: Vertex Pharmaceuticals Incorporated
• Contact: Medical Information
• Phone: 617-341-6777
• Email: medicalinfo[@]vrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 in healthy participants.

Description:

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VX-828
Suspension for Oral Administration
• Placebo
Suspension for Oral Administration
• Itraconazole
Solution for Oral Administration
• Midazolam
Syrup for Oral Administration

Locations

Country	Name	City	State
United States	Altasciences Clinical Kansas	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 34)
Primary	Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 61)
Primary	Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of Itraconazole		From Day 1 up to Day 71
Primary	Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of Itraconazole		From Day 1 up to Day 71
Primary	Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828		From Day 1 up to Day 30
Primary	Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828		From Day 1 up to Day 30
Secondary	Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma		From Day 1 up to Day 34
Secondary	Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma		From Day 1 up to Day 34
Secondary	Part B: Maximum Observed Concentration (Cmax) of VX-828 at Steady State in Plasma		From Day 1 up to Day 61
Secondary	Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-828 at Steady State in Plasma		From Day 1 up to Day 61
Secondary	Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Baseline up to Day 71