The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A:
- To evaluate the safety and tolerability of multiple doses of 750 mg qd of
VX-509 in healthy subjects.
Part B:
- To evaluate the effect of 200 mg qd (therapeutic) and 600 or 750 mg qd
(supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo
on the QT/QTc interval in healthy subjects.
Secondary outcome
Part A:
- To evaluate the pharmacokinetics (PK) in healthy subjects receiving multiple
doses of 750 mg qd of VX-509 for 7 days
Part B:
- To assess the effect of 200 mg qd (therapeutic dose) and 600 or 750 mg qd
(supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo
on non-QT interval electrocardiogram (ECG) parameters (heart rate [HR], RR, PR
and QRS interval) in healthy subjects.
- To assess the effects of a positive control (a single, oral dose of 400 mg of
moxifloxacin) on the QTc interval in healthy subjects, as an indicator of study
sensitivity.
- To determine the VX-509 plasma concentration-effect relationship for the
QT/QTc interval and the magnitude of the relationship, if any exist.
- To evaluate the PK of VX-509 in healthy subjects.
- To evaluate the safety and tolerability of therapeutic and supratherapeutic
systemic exposure of VX-509 in healthy subjects.
Background summary
VX-509 is a new investigational compound that may eventually be used for the
treatment of immune mediated disorders such as rheumatoid arthritis (RA).
VX-509 is an inhibitor of an enzyme (JAK-3) that contributes to the development
of inflammation in rheumatoid arthritis.
Study objective
The purpose of part A of the study is to investigate how safe the study drug is
and how well the study drug is tolerated. The study will also investigate how
quickly and to what extent the compound is absorbed and eliminated from the
body.
The purpose of part B of the study is to investigate if VX-509 has an effect on
the electrical activity of the heart. In addition, the safety of the compound
is investigated and how well the study drug is tolerated. The study will also
investigate how quickly and to what extent the compound is absorbed and
eliminated from the body.
Study design
Part A will be a double-blind, randomized, placebo-controlled study
investigating oral VX-509 doses of 750 mg qd in healthy male and female
subjects.
Part B of the study will be a double-blind (for VX-509/placebo; open label for
moxifloxacin), randomized, placebo- and active-controlled, single-center,
4-period crossover study to evaluate the effect of VX-509 on QT/QTc intervals
in healthy male and female subjects.
Intervention
Part A:
750 mg qd VX-509 or placebo as 15 tablets for 7 days.
Part B: The subjects will receive each one of the described treatments during
one of the periods in a random order.
Treatment A (Therapeutic Dose): 200 mg qd of VX-509 (4 × 50-mg tablets) and 8
or 11 placebo tablets each morning on Days 1 to 4, depending on determination
of supratherapeutic dose.
Treatment B (Supratherapeutic Dose): 600 or 750 mg qd (to be determined in Part
A) of VX-509 (12 or 15 × 50-mg tablets) each morning on Days 1 to 4.
Treatment C (Placebo Control): 12 or 15 placebo tablets each morning on Days 1
to 4, depending on choice of supratherapeutic dose.
Treatment D (Positive Control): a single 400-mg dose of moxifloxacin tablet in
the morning of Day 4, and 12 or 15 placebo tablets each morning on Days 1 to 4,
depending on determination of supratherapeutic dose.
Study burden and risks
During the study several assessments will be performed that may be perceived as
a burden. There will be a number of blood draws and in part B subjects will
receive a ECG monitor on 2 days each period (in total 8 days) which will
monitor their ECG continuously
Waverly street 130
Cambridge, Massachusetts 02139-4242
US
Waverly street 130
Cambridge, Massachusetts 02139-4242
US
Listed location countries
Age
Inclusion criteria
healthy male and female subjects
18-55 yrs, inclusive (part A)
18-45 yrs, inclusive (part B)
BMI: 18.0-31.0 kg/m2, inclusive
non-smoking
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003080-22-NL |
| CCMO | NL41343.056.12 |