A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 6308 IN HEALTHY VOLUNTEERS.

A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 6308 IN HEALTHY VOLUNTEERS. - EVP-6308 single and multiple ascending dose study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37679

Enrollment

Registered

2012-05-04

Start date

2012-05-11

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

delusions schizophrenia

Interventions

SAD part: Group 1 Period 1: a single oral dose of 5 mg EVP 6308 (n=6) or matching placebo (n=2) under fasted conditions Period 2: a single oral dose of 20 mg EVP 6308 (n=6) or matching placebo (n=2

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age : SAD part (Groups 1-3) and MAD part (Groups 4-7): 18-65 years, inclusive; BMI : 18.0 * 28.0 kg/m2, inclusive Gender : healthy male or female subjects; female subjects must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal)

Exclusion criteria

Exclusion criteria: Suffering from : hepatitis B. cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
Safety: AEs, vital signs, 12-lead ECG, clinical laboratory, prolactin, inhibin B and physical examination	—

Secondary

Measure	Time frame
PK : plasma concentrations of EVP 6308 and select metabolites, plasma and urine PK parameters; metabolite profiling of plasma if conducted, will be reported separately. PD : qEEG, Bond and Lader VAS and DSST	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)