A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

Healthy Clinical Trial

Official title:

A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547894
• Other study ID #: ASC-ASC09F-I-CTP-01
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: September 2020
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ASC09F
ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.

Locations

Country	Name	City	State
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.	Beijing YouAn Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Hoetelmans 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. — View Citation

Stellbrink HJ, Arastéh K, Schürmann D, Stephan C, Dierynck I, Smyej I, Hoetelmans RM, Truyers C, Meyvisch P, Jacquemyn B, Mariën 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of ASC09F	Evaluate the Area under the plasma concentration versus time curve after	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.
Primary	Cmax of ASC09F	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers.	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	t1/2 of ASC09F	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC09F administered to Chinese healthy volunteers volunteers.	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	CL/F of ASC09F	Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.	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	Vd/F of ASC09F	Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC09F administered to Chinese healthy volunteers.	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	Evaluation of the safety of ASC09F in healthy volunteers	Evaluate number of adverse events as a measure of safety of ASC09F.	Up to 11 days
Secondary	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.	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.