A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, ASCENDING MULTIPLE ORAL DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC AND PROOF OF MECHANISM STUDY OF CB-189,625 IN HEALTHY MALE SUBJECTS.

A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, ASCENDING MULTIPLE ORAL DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC AND PROOF OF MECHANISM STUDY OF CB-189,625 IN HEALTHY MALE SUBJECTS. - CB-189,625 MAD/POM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37104

Enrollment

Registered

2012-10-16

Start date

2012-10-23

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Acute- en chronische pijn Acute and chronic pain

Interventions

The first cohort of 10 subjects (Cohort 1) will receive 100 mg of CB-189,625 every 12 hours for a total of 5 doses or matching placebo containing equivalent concentrations of HP*CD. The second coh

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers Age : 18-55 jaar, inclusive BMI: 18.0 * 30.0 kg/m2, inclusive non-smoking

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B. cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of the study. In case of donating blood or significant loss of blood within 90 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability: adverse events, clinical laboratory data, vital signs, ECG, physical examination.	—

Secondary

Measure	Time frame
Pharmakinetics parameters: Analysis of variance (four factor-ANOVA) on Cmax and AUC, other parameters descriptive statistics Pharmacodynamic parameters: Analysis of mosterd oil and cinnamaldehyde challenges in healthy volunteers. Safety parameters: Descriptive statistics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)