Skip to content

A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects.

A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects. - CCX507-B SAD/MAD Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40895
Enrollment
30
Registered
2014-03-04
Start date
2014-03-27
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease. Inflammatory bowel diseases

Interventions

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 p

Sponsors

ChemoCentryx, Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female 18 - 65 years inclusive BMI 18.0 -30.0 kilograms/meter2 non smoker

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
* 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)