HealthyPhase 1NCT04845646
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
A Phase 1 study testing ASC41, Itraconazole and Phenytoin in people with Healthy and NAFLD, run by Gannex Pharma Co., Ltd. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- ASC41, Itraconazole and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 10 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part I Healthy subjects between 18 to 55 years of age
- Part II
- Subjects with NAFLD
- Subjects between 18 to 65 years of age
Who cannot join
- Part I
- A history of thyroid disease
- A history of, or current liver disease, or liver injuries
- Platelet count <150,000/mcL
- INR> 1.2
- History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator
Show all 16Show fewer
- Part II
- A history of thyroid disease
- Current or history of cirrhosis or decompensated liver disease
- AST or ALT > 5X ULN
- DBIL > ULN
- Acute or chronic liver disease other than NAFLD
- A history of bariatric surgery
- HbA1c >9.5% at screening
- Testosterone or estrogen replacement therapy
- Inducers or inhibitors of CYP3A4, including herbal therapies such as St John's Wort (CYP3A4 Inducer)
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON early Phase Services LLC
San Antonio, Texas, 78209
About this study
Official title: Phase I Open Label, Drug-Drug Interaction, Study to Evaluate the Effect of Itraconazole and Phenytoin on the Pharmacokinetics of ASC41 in Healthy Volunteers and A Study to Evaluate the PK, Safety and Tolerability in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD).
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.
Read the detailed description
This multiarm study in HVs and subjects with NAFLD is designed to further characterize the PK, safety and tolerability of ASC41. Part I of the study will assess the effect of itraconazole and phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD. The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and II. The secondary objective of the study is to characterize the safety and tolerability of oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female participants will be enrolled. This study consists of 3 cohorts.
- Being tested
- ASC41, Itraconazole, Phenytoin
- Keywords
- Healthy, NAFLD, DDI (Drug-Drug Interaction), Itraconazole, Phenytoin, THR beta agonist, ASC41
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC41Drug
5mg/tablet
ItraconazoleDrug
200mg/capsule
PhenytoinDrug
300mg/capsule
| Study group | Role | What they receive |
|---|---|---|
| ASC41 + Itraconazole group | Experimental | 1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11.
2. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16. Receives: Drug: ASC41; Drug: Itraconazole |
| ASC41 + Phenytoin group | Experimental | 1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19.
2. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19. Receives: Drug: ASC41; Drug: Phenytoin |
| ASC41 group | Experimental | (1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1. Receives: Drug: ASC41 |
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.
Measured: Up to 24 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration.
Measured: Up to 24 days
Secondary outcomes (4)
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life.
Measured: Up to 24 days
CL/F of ASC41
Evaluate the Apparent Systemic Clearance.
Measured: Up to 24 days
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution.
Measured: Up to 24 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 24 days.
Measured: Up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start16 Mar 2021
- Primary completion10 Jun 2021
- Study completion10 Jun 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845646
- Sponsor's protocol ID
- ASC41-105
- Status last verified
- Sep 2024
- First submitted
- 11 Apr 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
- Phase I Open Label, Drug-Drug Interaction, Study to Evaluate the Effect of Itraconazole and Phenytoin on the Pharmacokinetics of ASC41 in Healthy Volunteers and A Study to Evaluate the PK, Safety and Tolerability in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD).
- ClinicalTrials.gov ID
- NCT04845646
- Acronym / sponsor ID
- ASC41-105
- Keywords
- Healthy, NAFLD, DDI (Drug-Drug Interaction), Itraconazole, Phenytoin, THR beta agonist, ASC41
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 15 Apr 2021 (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.
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.
Detailed description
This multiarm study in HVs and subjects with NAFLD is designed to further characterize the PK, safety and tolerability of ASC41. Part I of the study will assess the effect of itraconazole and phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD. The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and II. The secondary objective of the study is to characterize the safety and tolerability of oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female participants will be enrolled. This study consists of 3 cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASC41 + Itraconazole group | Experimental | Drug: ASC41, Drug: Itraconazole1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11. 2. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16. |
| ASC41 + Phenytoin group | Experimental | Drug: ASC41, Drug: Phenytoin1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19. 2. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19. |
| ASC41 group | Experimental | Drug: ASC41(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Part I Healthy subjects between 18 to 55 years of age
- Part II
Key exclusion criteria (16 listed)
- Part I
- Part II
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 |
|---|---|---|
| ASC415mg/tablet | Drug | ASC41 + Itraconazole group, ASC41 + Phenytoin group, ASC41 group |
| Itraconazole200mg/capsule | Drug | ASC41 + Itraconazole group |
| Phenytoin300mg/capsule | Drug | ASC41 + Phenytoin group |
Primary outcome
AUC of ASC41
Time frame: Up to 24 days
Evaluate the Area under the plasma concentration versus time curve.
Cmax of ASC41
Time frame: Up to 24 days
Evaluate the Peak Plasma Concentration.
4 secondary outcomes
t1/2 of ASC41
Time frame: Up to 24 days
CL/F of ASC41
Time frame: Up to 24 days
Vd/F of ASC41
Time frame: Up to 24 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 24 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
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Itraconazole and Phenytoin in people with Healthy and NAFLD, run by Gannex Pharma Co., Ltd. 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 4 inclusion and 16 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 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?
AUC of ASC41 (time frame: Up to 24 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.