Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects

CoMentis

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: APN1125

Study type: Interventional

Funder types: Industry

Identifiers

NCT02331433

APN1125-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.

Full description

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females
• Aged 18 to 65 years, inclusive
• Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening
• Non-smoker or no tobacco/nicotine usage with 30 days of Screening

Exclusion criteria

• Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
• Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Experimental: 1

Experimental group

Treatment:

Drug: APN1125

Placebo Comparator: 2

Placebo Comparator group

Treatment:

Drug: Placebo