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Trial record 16 of 80 for:    ASNS

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

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ClinicalTrials.gov Identifier: NCT02853643
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ASN002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
Study Start Date : July 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Asparagine

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853643


Locations
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United States, Florida
InVentiv Health
Miami, Florida, United States, 33136
Sponsors and Collaborators
Asana BioSciences
Investigators
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Principal Investigator: David Wyatt, MD InVentiv Health Clinical Research Services

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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT02853643     History of Changes
Other Study ID Numbers: ASN002-102
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No