HealthyPhase 1NCT00789126
Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
A Phase 1 study testing VX-509 in people with Healthy, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VX-509
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to not given
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
- Able to comply with study procedures
- Male subjects must agree to use 2 highly effective methods of contraception
- Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
- No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results
Who cannot join
- History of any significant illness
- Illness within 5 days before Day 1
- Regular treatment with any medications
- Any type of tobacco or nicotine use
- History of drug or alcohol abuse or addiction within 2 years before Screening visit
- Positive tuberculin skin test at Screening
- Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects
Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects
Read the detailed description
Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.
Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.
A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
- Conditions
- Healthy
- Being tested
- VX-509
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-509Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
Measured: Specified timepoints in the protocol
Secondary outcomes (2)
Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax)
Measured: Specified timepoints in the protocol
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
Measured: Specified timepoints in the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- George Spencer-Green, MD, MS, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789126
- Sponsor's protocol ID
- VX08-509-002
- Status last verified
- Feb 2009
- First submitted
- 7 Nov 2008
- Last updated
- 19 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00789126
- Acronym / sponsor ID
- VX08-509-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- First posted
- 11 Nov 2008 (estimated)
- 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.
Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects
Detailed description
Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.
Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.
A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
Study design
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
- Able to comply with study procedures
- Male subjects must agree to use 2 highly effective methods of contraception
- Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
- No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results
Key exclusion criteria (7 listed)
- History of any significant illness
- Illness within 5 days before Day 1
- Regular treatment with any medications
- Any type of tobacco or nicotine use
- History of drug or alcohol abuse or addiction within 2 years before Screening visit
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 |
|---|---|---|
| VX-509 | Drug | – |
Primary outcome
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
Time frame: Specified timepoints in the protocol
2 secondary outcomes
Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax)
Time frame: Specified timepoints in the protocol
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
Time frame: Specified timepoints in the protocol
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 19 Feb 2009.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
George Spencer-Green, MD, MS study director
Vertex Pharmaceuticals Incorporated
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 VX-509 in people with Healthy, 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 5 inclusion and 7 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 19 Feb 2009. 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?
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables (time frame: Specified timepoints in the protocol). 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 19 Feb 2009.