Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT04843449
• Recruitment Status: Completed
• First Posted: April 13, 2021
• Last Update Posted: August 23, 2021
• Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Ascletis Pharmaceuticals Co., Ltd.

Tracking Information

• First Submitted Date: April 9, 2021
• First Posted Date: April 13, 2021
• Last Update Posted Date: August 23, 2021
• Actual Study Start Date: April 4, 2021
• Actual Primary Completion Date: May 6, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 12, 2021)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 12, 2021)

• t1/2 of ASC40 [ Time Frame: Up to 24 days ]
  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.
• CL/F of ASC40 [ Time Frame: Up to 24 days ]
  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.
• Vd/F of ASC40 [ Time Frame: Up to 24 days ]
  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.
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 24 days ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Drug: ASC40
  Oral tablets
• Drug: Itraconazole
  Oral capsules
• Drug: rifampicin
  Oral capsules

Study Arms

• Experimental: Inhibitor group
  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.
  Interventions:

  • Drug: ASC40
  • Drug: Itraconazole
• Experimental: Inducer group
  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.
  Interventions:

  • Drug: ASC40
  • Drug: rifampicin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2021): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 14, 2021
• Actual Primary Completion Date: May 6, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

-19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

• History of, or current digestive system, nervous system disease, etc..
• Taking drugs or foods that inhibit or induce the liver's metabolism.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04843449
• Other Study ID Numbers: ASC40-102
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ascletis Pharmaceuticals Co., Ltd.
• Verification Date: August 2021