HealthyPhase 1NCT04692025
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
A Phase 1 study testing ASC41 tablet in people with Healthy and NAFLD, run by Gannex Pharma Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, NAFLD, Hyperlipidemia
- What is being tested?
- ASC41 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2020to 21 Jan 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19kg/m2 ≤ BMI <40kg/m2.
Who cannot join
- A history of thyroid disease.
- History of, or current liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
- Conditions
- Healthy, NAFLD, Hyperlipidemia
- Being tested
- ASC41 tablet
- Keywords
- Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC41 tabletDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal. Receives: Drug: ASC41 tablet |
| Group 2 | Experimental | ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal. Receives: Drug: ASC41 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Measured: Up to 19 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
Measured: Up to 19 days
Secondary outcomes (4)
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.
Measured: Up to 19 days
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.
Measured: Up to 19 days
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.
Measured: Up to 19 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 19 days
Measured: Up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start27 Dec 2020
- Primary completion14 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692025
- Sponsor's protocol ID
- ASC41-103
- Status last verified
- Sep 2024
- First submitted
- 29 Dec 2020
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04692025
- Acronym / sponsor ID
- ASC41-103
- Conditions
- Healthy, NAFLD, Hyperlipidemia
- Keywords
- Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- 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.
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ASC41 tabletASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal. |
| Group 2 | Experimental | Drug: ASC41 tabletASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 19kg/m2 ≤ BMI <40kg/m2.
Key exclusion criteria (2 listed)
- A history of thyroid disease.
- History of, or current liver disease.
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 |
|---|---|---|
| ASC41 tabletOral tablet | Drug | Group 1, Group 2 |
Primary outcome
AUC of ASC41
Time frame: Up to 19 days
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Cmax of ASC41
Time frame: Up to 19 days
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
4 secondary outcomes
t1/2 of ASC41
Time frame: Up to 19 days
CL/F of ASC41
Time frame: Up to 19 days
Vd/F of ASC41
Time frame: Up to 19 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 19 days
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 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ASC41 tablet in people with Healthy and NAFLD, run by Gannex Pharma Co., Ltd. at 1 site in China.
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 1 inclusion and 2 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 27 Sep 2024. 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 China. 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?
AUC of ASC41 (time frame: Up to 19 days). The study lists 2 primary outcomes in all. 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 27 Sep 2024.