HealthyPhase 1NCT04547894
A Study of the Pharmacokinetics of ASC09F in Healthy Subjects
A Phase 1 study testing ASC09F in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ASC09F
- 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
- 9 Nov 2020to 7 Dec 2020
- 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
- 1. Age 18-45 (including boundary value), half men and half women. 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- 3. According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.
- 4. Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.
- 5. The pregnancy test of female subjects during the screening period is negative.
- 6. Those who voluntarily sign the informed consent.
Who cannot join
- 1. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.
- 2. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- 3. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
- 4. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
- 5. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
- 6. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
- 7. Alcoholic or nonalcoholic fatty liver disease. 8. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses
The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.
Read the detailed description
This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.
- Conditions
- Healthy
- Being tested
- ASC09F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC09FDrug
ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| ASC09F | Experimental | ASC09F one tablet at a time, once per day, up to 7 days. Receives: Drug: ASC09F |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ASC09F
Evaluate the Area under the plasma concentration versus time curve after
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Cmax of ASC09F
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Secondary outcomes (5)
t1/2 of ASC09F
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
CL/F of ASC09F
Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Vd/F of ASC09F
Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluation of the safety of ASC09F in healthy volunteers
Evaluate number of adverse events as a measure of safety of ASC09F.
Measured: Up to 11 days
Tmax of ASC09F
Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start9 Nov 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing YouAn Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547894
- Sponsor's protocol ID
- ASC-ASC09F-I-CTP-01
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dierynck I, Van Marck H, Van Ginderen M, Jonckers TH, Nalam MN, Schiffer CA, Raoof A, Kraus G, Picchio G. TMC310911, a novel human immunodeficiency virus type 1 protease inhibitor, shows in vitro an improved resistance profile and higher genetic barrier to resistance compared with current protease inhibitors. Antimicrob Agents Chemother. 2011 Dec;55(12):5723-31. doi: 10.1128/AAC.00748-11. Epub 2011 Sep 6.
PubMed 21896904Hoetelmans RM, Dierynck I, Smyej I, Meyvisch P, Jacquemyn B, Marien K, Simmen K, Verloes R. Safety and pharmacokinetics of the HIV-1 protease inhibitor TMC310911 coadministered with ritonavir in healthy participants: results from 2 phase 1 studies. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):299-305. doi: 10.1097/QAI.0000000000000011.
PubMed 24121757Stellbrink HJ, Arasteh K, Schurmann D, Stephan C, Dierynck I, Smyej I, Hoetelmans RM, Truyers C, Meyvisch P, Jacquemyn B, Marien K, Simmen K, Verloes R. Antiviral activity, pharmacokinetics, and safety of the HIV-1 protease inhibitor TMC310911, coadministered with ritonavir, in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):283-9. doi: 10.1097/QAI.0000000000000003.
PubMed 24121756
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses
- ClinicalTrials.gov ID
- NCT04547894
- Acronym / sponsor ID
- ASC-ASC09F-I-CTP-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing YouAn Hospital
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 14 Sep 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.
The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.
Detailed description
This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASC09F | Experimental | Drug: ASC09FASC09F one tablet at a time, once per day, up to 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Age 18-45 (including boundary value), half men and half women. 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- 3. According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.
- 4. Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.
- 5. The pregnancy test of female subjects during the screening period is negative.
- 6. Those who voluntarily sign the informed consent.
Key exclusion criteria (7 listed)
- 1. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.
- 2. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- 3. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
- 4. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
- 5. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
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 |
|---|---|---|
| ASC09FASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days. | Drug | ASC09F |
Primary outcome
AUC of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluate the Area under the plasma concentration versus time curve after
Cmax of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.
5 secondary outcomes
t1/2 of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
CL/F of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Vd/F of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 days.
Evaluation of the safety of ASC09F in healthy volunteers
Time frame: Up to 11 days
Tmax of ASC09F
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 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 11 Jan 2021.
- Background: PubMed 21896904Dierynck I, Van Marck H, Van Ginderen M, Jonckers TH, Nalam MN, Schiffer CA, Raoof A, Kraus G, Picchio G. TMC310911, a novel human immunodeficiency virus type 1 protease inhibitor, shows in vitro an improved resistance profile and higher genetic barrier to resistance compared with current protease inhibitors. Antimicrob Agents Chemother. 2011 Dec;55(12):5723-31. doi: 10.1128/AAC.00748-11. Epub 2011 Sep 6.
- Background: PubMed 24121757Hoetelmans RM, Dierynck I, Smyej I, Meyvisch P, Jacquemyn B, Marien K, Simmen K, Verloes R. Safety and pharmacokinetics of the HIV-1 protease inhibitor TMC310911 coadministered with ritonavir in healthy participants: results from 2 phase 1 studies. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):299-305. doi: 10.1097/QAI.0000000000000011.
- Background: PubMed 24121756Stellbrink HJ, Arasteh K, Schurmann D, Stephan C, Dierynck I, Smyej I, Hoetelmans RM, Truyers C, Meyvisch P, Jacquemyn B, Marien K, Simmen K, Verloes R. Antiviral activity, pharmacokinetics, and safety of the HIV-1 protease inhibitor TMC310911, coadministered with ritonavir, in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):283-9. doi: 10.1097/QAI.0000000000000003.
- 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 ASC09F 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 5 inclusion and 7 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 11 Jan 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 ASC09F (time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 11 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?
On the ClinicalTrials.gov record for NCT04547894, which also lists 3 linked publications.
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 11 Jan 2021.