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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ASN002

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • InVentiv Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 25 mg Dose; Single dose of 25 mg ASN002	Drug: ASN002; Single dose study with food effect
Experimental: 50 mg Dose; Single dose of 50 mg ASN002	Drug: ASN002; Single dose study with food effect
Experimental: 100 mg Food effect cross over; 100 mg single dose under both fasted and fed conditions in a cross over fashion	Drug: ASN002; Single dose study with food effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Drug half life of ASN002	Calculate terminal elimination rate constant and terminal half-life of ASN002	Days 1-6
Drug half life of ASN002 under fed and fasted conditions	Calculate terminal elimination rate constant and terminal half-life of ASN002	Days 1-6

Collaborators and Investigators

• Sponsor: Asana BioSciences
• Investigators: Principal Investigator: David Wyatt, MD, InVentiv Health Clinical Research Services

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ASN002-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO