Clinical trial NCT02853643: Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers
Official title: A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Asana BioSciences
Sponsor class: INDUSTRY
First posted: 2016-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects reporting adverse events during the study
timeFrame: Days 1-28
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Days 1-6
measure: Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions
timeFrame: Days 1-6
measure: Maximum Plasma Concentration of ASN002
timeFrame: Days 1-6
measure: Maximum Plasma Concentration of ASN002 under fed and fasted conditions
timeFrame: Days 1-6
measure: Drug half life of ASN002
timeFrame: Days 1-6
measure: Drug half life of ASN002 under fed and fasted conditions
timeFrame: Days 1-6
Other outcomes:
Locations:
city: Miami
country: United States
facility: InVentiv Health
state: Florida
Study officials:
affiliation: InVentiv Health Clinical Research Services
name: David Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
References: