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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853643
• Other study ID #: ASN002-102
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2023
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ASN002
Single dose study with food effect

Locations

Country	Name	City	State
United States	InVentiv Health	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting adverse events during the study	Safety and tolerability will be determined by the number of subjects reporting adverse events during the study.	Days 1-28
Secondary	Area under the plasma concentration versus time curve (AUC)	Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.	Days 1-6
Secondary	Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions	Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.	Days 1-6
Secondary	Maximum Plasma Concentration of ASN002	Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.	Days 1-6
Secondary	Maximum Plasma Concentration of ASN002 under fed and fasted conditions	Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.	Days 1-6
Secondary	Drug half life of ASN002	Calculate terminal elimination rate constant and terminal half-life of ASN002	Days 1-6
Secondary	Drug half life of ASN002 under fed and fasted conditions	Calculate terminal elimination rate constant and terminal half-life of ASN002	Days 1-6