HealthyPhase 1NCT04843449
Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
A Phase 1 study testing ASC40, Itraconazole and rifampicin in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ASC40, Itraconazole and rifampicin
- 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 siteChina
- Study dates
- 4 Apr 2021to 14 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -19kg/m2 ≤ BMI <40kg/m2.
Who cannot join
- History of, or current digestive system, nervous system disease, etc..
- Taking drugs or foods that inhibit or induce the liver's metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ASC40, Itraconazole, rifampicin
- Keywords
- Healthy Volunteers, DDI (Drug-Drug Interaction), Itraconazole, Rifampicin, ASC40
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC40Drug
Oral tablets
ItraconazoleDrug
Oral capsules
rifampicinDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Inhibitor group | Experimental | 1. ASC40 50mg, once daily on the 1st and 11th days before meal;
2. Itraconazole 200mg, once daily from the 6th day to the 15th day. Receives: Drug: ASC40; Drug: Itraconazole |
| Inducer group | Experimental | 1. ASC40 50mg, once daily on the 1st and 19th days before meal;
2. Rifampicin 600mg, once daily from the 6th day to the 19th day. Receives: Drug: ASC40; Drug: rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ASC40
Evaluate the Area under the Plasma Concentration Versus Time Curve after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Measured: Up to 24 days
Cmax of ASC40
Evaluate the Peak Plasma Concentration after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Measured: Up to 24 days
Secondary outcomes (4)
t1/2 of ASC40
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Measured: Up to 24 days
CL/F of ASC40
Evaluate the Apparent Systemic Clearance after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Measured: Up to 24 days
Vd/F of ASC40
Evaluate the Apparent Volume of Distribution after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
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 posted13 Apr 2021
- Study start4 Apr 2021
- Primary completion6 May 2021
- Study completion14 May 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
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843449
- Sponsor's protocol ID
- ASC40-102
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2021
- Last updated
- 23 Aug 2021
- 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04843449
- Acronym / sponsor ID
- ASC40-102
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, DDI (Drug-Drug Interaction), Itraconazole, Rifampicin, ASC40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 13 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 effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitor group | Experimental | Drug: ASC40, Drug: Itraconazole1. ASC40 50mg, once daily on the 1st and 11th days before meal; 2. Itraconazole 200mg, once daily from the 6th day to the 15th day. |
| Inducer group | Experimental | Drug: ASC40, Drug: rifampicin1. ASC40 50mg, once daily on the 1st and 19th days before meal; 2. Rifampicin 600mg, once daily from the 6th day to the 19th day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -19kg/m2 ≤ BMI <40kg/m2.
Key exclusion criteria (2 listed)
- History of, or current digestive system, nervous system disease, etc..
- Taking drugs or foods that inhibit or induce the liver's metabolism.
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 |
|---|---|---|
| ASC40Oral tablets | Drug | Inducer group, Inhibitor group |
| ItraconazoleOral capsules | Drug | Inhibitor group |
| rifampicinOral capsules | Drug | Inducer group |
Primary outcome
AUC of ASC40
Time frame: Up to 24 days
Evaluate the Area under the Plasma Concentration Versus Time Curve after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Cmax of ASC40
Time frame: Up to 24 days
Evaluate the Peak Plasma Concentration after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
4 secondary outcomes
t1/2 of ASC40
Time frame: Up to 24 days
CL/F of ASC40
Time frame: Up to 24 days
Vd/F of ASC40
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 23 Aug 2021.
- 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 ASC40, Itraconazole and rifampicin in people with Healthy, run by Ascletis Pharmaceuticals 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 23 Aug 2021. 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 ASC40 (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 23 Aug 2021.