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

A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CROSS-OVER, ASCENDING SINGLE ORAL DOSE, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF CB-189,625 IN HEALTHY MALE SUBJECTS. - CB-189,625 SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37794

Enrollment

Registered

2012-01-03

Start date

2012-02-05

Completion date

Unknown

Last updated

2024-05-06

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

Cohort 1: period 1: a single oral dose of 200 mg CB-189,625 or placebo. period 3: a single oral dose of 800 mg CB-189,625 or placebo. period 5: a single oral dose of 1600 mg CB-189,625 or placebo. Co

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-55 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 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 outcomes

Primary

Measure	Time frame
Safety and tolerability: AEs, clinical laboratory data, vital sings, ECG, physical examination	—

Secondary

Measure	Time frame
Pharmacokinetics: concentrations of CB-189,625, PK parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)