Trial | NCT02331433  Report issue

Title

Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    apn-1125 ...

  • Study Participants

    58
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
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.
Study Started
Dec 31
2014
Primary Completion
Nov 30
2015
Study Completion
Dec 31
2015
Last Update
Apr 08
2016
Estimate

Drug APN1125

APN1125 orally at ascending doses

Drug Placebo

Matching Placebo

Experimental: 1 Experimental

Placebo Comparator: 2 Placebo Comparator

Criteria 

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
No Results Posted