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Completed

NCT Number: NCT02853643

Single Ascending Dose Study to Evaluate 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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

InVentiv Health

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

ASN002

Drug

Single dose study with food effect

Primary outcomes

  1. Number of subjects reporting adverse events during the study

    Time frame: Days 1-28

    Safety and tolerability will be determined by the number of subjects reporting adverse events during the study.

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: Days 1-6

    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.

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

    Time frame: Days 1-6

    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.

  3. Maximum Plasma Concentration of ASN002

    Time frame: Days 1-6

    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.

  4. Maximum Plasma Concentration of ASN002 under fed and fasted conditions

    Time frame: Days 1-6

    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.

  5. Drug half life of ASN002

    Time frame: Days 1-6

    Calculate terminal elimination rate constant and terminal half-life of ASN002

  6. Drug half life of ASN002 under fed and fasted conditions

    Time frame: Days 1-6

    Calculate terminal elimination rate constant and terminal half-life of ASN002

Sponsors and collaborators

Lead sponsor

Asana BioSciences

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2016
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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