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A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 0962 IN HEALTHY VOLUNTEERS

A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 0962 IN HEALTHY VOLUNTEERS - EVP-0962 single and multiple ascending dose study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35950
Enrollment
84
Registered
2011-04-11
Start date
2011-04-12
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

Alzheimers Disease

Interventions

Treatments SAD part: single oral dose administration of EVP-0962 or matching placebo, as follows: Cohort 1 Period 1 : 10 mg EVP 0962 or matching placebo in fasted conditions Period 2 : 50 mg EVP 09

Sponsors

EnVivo Pharmaceuticals, Inc.
Lead Sponsor

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; MAD part (Group 8): 66-80 years 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

MeasureTime frame
safety tolerability pharmacokinetic pharmacodynamic food effect—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)