Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT02853643
- Run by
- Asana BioSciences
- People needed
- 22
- Starts
- 2016-07-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2023-04-14
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female, non-smoking subjects.
- Willing to use contraception throughout the duration of the study and for 90 days after the study.
- Capable of consent.
You may not qualify if…
- Subjects to whom any of the following applies will be excluded from the study:
- Any clinically significant abnormality, infection, exposure to infection, recent live virus vaccination, or abnormal laboratory test results found during medical screening.
- History of alcohol or drug abuse, or a positive urine drug screen or breath alcohol test at screening.
- History of allergic reactions to protein kinase inhibitors, or significant allergic reactions to any drug.
- Positive pregnancy test at screening.
- Clinically significant ECG abnormalities.
- 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.
- Use of medication other than topical products without significant systemic absorption:
- Donation of plasma within 7 days prior to dosing, or significant blood loss within the past 56 days.
- Subject is pregnant, or breast feeding.
Where it is running
- InVentiv Health — Miami, Florida, United States
Full record on ClinicalTrials.gov
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