A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC AND FOOD EFFECT OF BCI 838 AND AN OPEN-LABEL MINIDOSE BIOAVAILABILITY STUDY TO COMPARE SEVERAL BCI-632 PRO-DRUG CANDIDATES IN HEALTHY MALE SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC AND FOOD EFFECT OF BCI 838 AND AN OPEN-LABEL MINIDOSE BIOAVAILABILITY STUDY TO COMPARE SEVERAL BCI-632 PRO-DRUG CANDIDATES IN HEALTHY MALE SUBJECTS - BCI-838 SAD and minidose bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35311

Enrollment

Registered

2011-09-26

Start date

2011-10-12

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

depression mood disorders

Interventions

Study Medication Active medication: Active substance: BCI-838 Activity: antagonism of metabotropic glutamate receptors 2 and 3 Indication: mood disorders or cognitive impairment Dosage form: oral caps

PK parameters in plasma Treatments SAD part Group 1(integrated FE part): Period 1: a single oral dose of 30 mg BCI-838 (n=6) or placebo (n=2) on Day 1 in the fasted state Period 2: a single oral do

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male - 18-55 years of age, inclusive - BMI 18-30 kg/m2, inclusive - non-smoker or moderate smoker (* 5 cigarettes per day)

Exclusion criteria

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 the study.

Design outcomes

Primary

Measure	Time frame
Criteria for evaluation Safety: AEs, vital signs, 12-lead ECG, clinical laboratory and physical examination PK: plasma concentrations of BCI-838 and metabolite BCI-632; PK parameters in plasma	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)