A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

NCT04547894 | Completed Phase 1

• 1 other identifier: ASC-ASC09F-I-CTP-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• t1/2 of ASC09F

  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

  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

  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

  Up to 11 days

• Tmax of ASC09F

  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.

Study Arms (1)

ASC09F

EXPERIMENTAL

ASC09F one tablet at a time, once per day, up to 7 days.

Drug: ASC09F

Interventions

ASC09F DRUG

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

ASC09F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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).
• \. 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.
• \. 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.
• \. The pregnancy test of female subjects during the screening period is negative.
• \. Those who voluntarily sign the informed consent.

You may not qualify if:

• \. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.
• \. 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.
• \. 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.
• \. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
• \. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
• \. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
• \. 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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead
• Beijing YouAn Hospital: collaborator

Study Sites (1)

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Related 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.

  PMID: 21896904 BACKGROUND

• 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.

  PMID: 24121757 BACKGROUND

• Stellbrink 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.

  PMID: 24121756 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: November 9, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: January 11, 2021

Record last verified: 2020-09

Locations

CN (1)