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

NCT02853643 | Completed Phase 1

• 1 other identifier: ASN002-102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Area under the plasma concentration versus time curve (AUC)

  Days 1-6

• Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions

  Days 1-6

• Maximum Plasma Concentration of ASN002

  Days 1-6

• Maximum Plasma Concentration of ASN002 under fed and fasted conditions

  Days 1-6

• Drug half life of ASN002

  Days 1-6

Study Arms (3)

25 mg Dose

EXPERIMENTAL

Single dose of 25 mg ASN002

Drug: ASN002

50 mg Dose

EXPERIMENTAL

Single dose of 50 mg ASN002

Drug: ASN002

100 mg Food effect cross over

EXPERIMENTAL

100 mg single dose under both fasted and fed conditions in a cross over fashion

Drug: ASN002

Interventions

ASN002 DRUG

Single dose study with food effect

100 mg Food effect cross over; 25 mg Dose; 50 mg Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (1)

InVentiv Health

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

gusacitinib

Study Officials

• David Wyatt, MD

  InVentiv Health Clinical Research Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 3, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)