Cystic FibrosisPhase 1NCT05867147
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
A Phase 1 study testing Vanzacaftor and Moxifloxacin in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vanzacaftor and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 14 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive
- Male and female participants of age 18 to 45 years, both inclusive
- Serum potassium, calcium, and magnesium values within normal ranges
Who cannot join
- Median QTcF>450 msec on triplicate 12-lead ECGs
- History of conduction abnormalities
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Thorough QT/QTc Study of Vanzacaftor Monotherapy in Healthy Subjects
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
Read the detailed 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.).
- Conditions
- Cystic Fibrosis
- Being tested
- Vanzacaftor, Vanzacaftor Placebo, Moxifloxacin, Moxifloxacin Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VanzacaftorDrug
Tablets for oral administration.
Vanzacaftor PlaceboDrug
Placebo for oral administration.
MoxifloxacinDrug
Tablets for oral administration.
Moxifloxacin PlaceboDrug
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. Receives: Drug: Vanzacaftor; Drug: Vanzacaftor Placebo; Drug: Moxifloxacin Placebo |
| Group 2A | Active comparator | Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. Receives: Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
| Group 2B | Active comparator | Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Receives: Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT interval corrected by Fridericia's formula (QTcF)
Measured: From Baseline up to Day 23
Secondary outcomes (16)
Change in Heart Rate (HR)
Measured: From Baseline up to Day 23
Change in PR interval, segment
Measured: From Baseline up to Day 23
Change in QRS duration
Measured: From Baseline up to Day 23
Placebo-corrected Change in QTcF
Measured: From Baseline up to Day 23
Placebo-corrected Change in HR
Measured: From Baseline up to Day 23
Placebo-corrected Change in PR interval
Measured: From Baseline up to Day 23
Placebo-corrected Change in QRS duration
Measured: From Baseline up to Day 23
Number of Outliers for QTcF
Measured: From Baseline up to Day 23
Number of Outliers for HR
Measured: From Baseline up to Day 23
Number of Outliers for PR interval
Measured: From Baseline up to Day 23
Number of Outliers for QRS duration
Measured: From Baseline up to Day 23
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Measured: From Baseline up to Day 23
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day -2 up to Day 38
Maximum Observed Plasma Concentration (Cmax) of VNZ
Measured: Days 11 and 21
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ
Measured: Days 11 and 21
Time Taken for VNZ to Reach Maximum Concentration (tmax)
Measured: Days 11 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start26 Apr 2023
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867147
- Sponsor's protocol ID
- VX22-121-013
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Thorough QT/QTc Study of Vanzacaftor Monotherapy in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05867147
- Acronym / sponsor ID
- VX22-121-013
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
Detailed 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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Vanzacaftor, Drug: Vanzacaftor Placebo, Drug: Moxifloxacin PlaceboParticipants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. |
| Group 2A | Active comparator | Drug: Vanzacaftor Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboParticipants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. |
| Group 2B | Active comparator | Drug: Vanzacaftor Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboParticipants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive
- Male and female participants of age 18 to 45 years, both inclusive
- Serum potassium, calcium, and magnesium values within normal ranges
Key exclusion criteria (3 listed)
- Median QTcF>450 msec on triplicate 12-lead ECGs
- History of conduction abnormalities
- Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VanzacaftorTablets for oral administration. | Drug | Group 1 |
| Vanzacaftor PlaceboPlacebo for oral administration. | Drug | Group 1, Group 2A, Group 2B |
| MoxifloxacinTablets for oral administration. | Drug | Group 2A, Group 2B |
| Moxifloxacin PlaceboTablets for oral administration. | Drug | Group 1, Group 2A, Group 2B |
Primary outcome
Change in QT interval corrected by Fridericia's formula (QTcF)
Time frame: From Baseline up to Day 23
16 secondary outcomes
Change in Heart Rate (HR)
Time frame: From Baseline up to Day 23
Change in PR interval, segment
Time frame: From Baseline up to Day 23
Change in QRS duration
Time frame: From Baseline up to Day 23
Placebo-corrected Change in QTcF
Time frame: From Baseline up to Day 23
Placebo-corrected Change in HR
Time frame: From Baseline up to Day 23
Placebo-corrected Change in PR interval
Time frame: From Baseline up to Day 23
Placebo-corrected Change in QRS duration
Time frame: From Baseline up to Day 23
Number of Outliers for QTcF
Time frame: From Baseline up to Day 23
Number of Outliers for HR
Time frame: From Baseline up to Day 23
Number of Outliers for PR interval
Time frame: From Baseline up to Day 23
Number of Outliers for QRS duration
Time frame: From Baseline up to Day 23
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Time frame: From Baseline up to Day 23
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -2 up to Day 38
Maximum Observed Plasma Concentration (Cmax) of VNZ
Time frame: Days 11 and 21
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ
Time frame: Days 11 and 21
Time Taken for VNZ to Reach Maximum Concentration (tmax)
Time frame: Days 11 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vanzacaftor and Moxifloxacin in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QT interval corrected by Fridericia's formula (QTcF) (time frame: From Baseline up to Day 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.