Healthy VolunteersPhase 1NCT02853643
Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers
A Phase 1 study testing ASN002 in people with Healthy Volunteers, run by Asana BioSciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASN002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- ASN002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN002Drug
Single dose study with food effect
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Dose | Experimental | Single dose of 25 mg ASN002 Receives: Drug: ASN002 |
| 50 mg Dose | Experimental | Single dose of 50 mg ASN002 Receives: Drug: ASN002 |
| 100 mg Food effect cross over | Experimental | 100 mg single dose under both fasted and fed conditions in a cross over fashion Receives: Drug: ASN002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1-28
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1-6
Drug half life of ASN002
Calculate terminal elimination rate constant and terminal half-life of ASN002
Measured: Days 1-6
Drug half life of ASN002 under fed and fasted conditions
Calculate terminal elimination rate constant and terminal half-life of ASN002
Measured: Days 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wyatt, MD, Principal investigator, InVentiv Health Clinical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853643
- Sponsor's protocol ID
- ASN002-102
- Status last verified
- Apr 2023
- First submitted
- 28 Jul 2016
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02853643
- Acronym / sponsor ID
- ASN002-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg Dose | Experimental | Drug: ASN002Single dose of 25 mg ASN002 |
| 50 mg Dose | Experimental | Drug: ASN002Single dose of 50 mg ASN002 |
| 100 mg Food effect cross over | Experimental | Drug: ASN002100 mg single dose under both fasted and fed conditions in a cross over fashion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASN002Single dose study with food effect | Drug | 100 mg Food effect cross over, 25 mg Dose, 50 mg Dose |
Primary outcome
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.
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Days 1-6
Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions
Time frame: Days 1-6
Maximum Plasma Concentration of ASN002
Time frame: Days 1-6
Maximum Plasma Concentration of ASN002 under fed and fasted conditions
Time frame: Days 1-6
Drug half life of ASN002
Time frame: Days 1-6
Drug half life of ASN002 under fed and fasted conditions
Time frame: Days 1-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wyatt, MD principal investigator
InVentiv Health Clinical Research Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASN002 in people with Healthy Volunteers, run by Asana BioSciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting adverse events during the study (time frame: Days 1-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.