Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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25 mg Dose

Single dose of 25 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Single dose study with food effect

50 mg Dose

Single dose of 50 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Single dose study with food effect

100 mg Food effect cross over

100 mg single dose under both fasted and fed conditions in a cross over fashion

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Single dose study with food effect

Interventions

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ASN002

Single dose study with food effect

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male or female, non-smoking subjects.
2. Willing to use contraception throughout the duration of the study and for 90 days after the study.
3. Capable of consent.

Exclusion Criteria

Subjects to whom any of the following applies will be excluded from the study:

1. Any clinically significant abnormality, infection, exposure to infection, recent live virus vaccination, or abnormal laboratory test results found during medical screening.
2. History of alcohol or drug abuse, or a positive urine drug screen or breath alcohol test at screening.
3. History of allergic reactions to protein kinase inhibitors, or significant allergic reactions to any drug.
4. Positive pregnancy test at screening.
5. Clinically significant ECG abnormalities.
6. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
7. Use of medication other than topical products without significant systemic absorption:
8. Donation of plasma within 7 days prior to dosing, or significant blood loss within the past 56 days.
9. Subject is pregnant, or breast feeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes