The purpose of the study is to investigate to what extent CCX507-B is safe and tolerated. It will also be investigated how quickly and to what extent CCX507-B is absorbed and eliminated from the body (this is called pharmacokinetics). In addition,…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the safety and tolerability
of single and multiple oral doses of CCX507-B, over a range of 3 dose levels,
in healthy male and female subjects.
Secondary outcome
* The effect of food on the PK profile of CCX507-B; and
* The relationship between CCX507 plasma concentrations and blockade of the C-C
chemokine receptor 9 (CCR9) on circulating leukocytes.
Background summary
CCX507-B is a new investigational compound that may eventually be used for the
treatment of inflammatory bowel diseases, such as Crohn*s disease. The active
part of CCX507-B is CCX507. CCX507 is capable of blocking a protein that is
involved in inflammatory reactions in the bowels. CCX507-B is in development
and not registered as an approved drug, but has been given to humans before. In
addition, CCX507 has also been administered to humans in the form of CCX507-H
(this has a slightly different composition but the same active part).
Study objective
The purpose of the study is to investigate to what extent CCX507-B is safe and
tolerated. It will also be investigated how quickly and to what extent CCX507-B
is absorbed and eliminated from the body (this is called pharmacokinetics). In
addition, the effect of the compound on the white blood cells (blood cells
actively involved in the immune response) will be investigated (this is called
pharmacodynamics). Finally, the effect of food on the effectiveness of the
compound will be investigated.
Study design
The study will consist of 2 periods. In the first period the subject will
receive once CCX507-B or placebo. In the second period the subjectl receive
multiple doses of CCX507-B or placebo. If the subject participates in Group 1
or 2, they will receive CCX507-B or placebo first once daily for 4 days and
thereafter twice daily for 3 days. If they participate in Group 3, they will
receive CCX507-B or placebo once daily for 7 days. CCX507-B and placebo will be
given in the form of oral capsules.
Intervention
Group 1a:
30 mg CCX507-B or placebo once (in fasted state)
30 mg CCX507-B or placebo once daily (in fasted state)
30 mg CCX507-B or placebo twice daily (in fasted state)
Group 1b:
30 mg CCX507-B or placebo once (after breakfast)
30 mg CCX507-B or placebo once daily (after breakfast)
30 mg CCX507-B or placebo twice daily (after breakfast and dinner)
Group 2a:
60 mg CCX507-B or placebo once (in fasted state)
60 mg CCX507-B or placebo once daily (in fasted state)
60 mg CCX507-B or placebo twice daily (in fasted state)
Group 2b:
60 mg CCX507-B or placebo once (after breakfast)
60 mg CCX507-B or placebo once daily (after breakfast)
60 mg CCX507-B or placebo twice daily (after breakfast and dinner)
Group 3a:
90 mg CCX507-B or placebo once (in fasted state)
90 mg CCX507-B or placebo once daily (in fasted state)
Group 3b:
90 mg CCX507-B or placebo once (after breakfast)
90 mg CCX507-B or placebo once daily (after breakfast)
Study burden and risks
Blood sampling, indwelling cannula: During this study less than 500 milliliters
of blood will be drawn.
An indwelling cannula will be used once per period (so in total twice). The
remainder of the blood draws will be drawn by direct puncture of the vein.
Collection of urine, feces and expired air.
Urine will be collected for 24 hours starting after administration of CCX507-B
or placebo on Day 7 of Period 2.
Vital signs: Blood pressure, pulse rate and body temperature will be measured
regularly in supine position.
On several occasions, this will also be done in the standing position.
Heart trace (ECG): ECGs will be made regularly: especially frequent on the days
of first medication administration in each period (Days 1) and on the last day
of medication administration in Period 2 (Day 7).
Maude Avenue 850
Mountain View CA 94043
US
Maude Avenue 850
Mountain View CA 94043
US
Listed location countries
Age
Inclusion criteria
Healthy male or female
18 - 65 years inclusive
BMI 18.0 -30.0 kilograms/meter2
non smoker
Exclusion criteria
Suffering form hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in another drug study within 60 days prior to randomization.
Any donation of blood (products) or significant blood loss within 56 days prior to screening.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2014-000373-39-NL |
CCMO | NL48148.056.14 |