Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 1/25/2017 |
Start Date: | July 2016 |
End Date: | December 2016 |
A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
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.
blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of
ASN002. Healthy volunteers will be participants in the study.
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.
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