NCT04843449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

April 9, 2021

Last Update Submit

August 19, 2021

Conditions

Healthy

Keywords

Healthy VolunteersDDI (Drug-Drug Interaction)ItraconazoleRifampicinASC40

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 24 days

Secondary Outcomes (4)

  • t1/2 of ASC40

    Up to 24 days

  • CL/F of ASC40

    Up to 24 days

  • Vd/F of ASC40

    Up to 24 days

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Up to 24 days

Study Arms (2)

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.

Drug: ASC40Drug: 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.

Drug: ASC40Drug: rifampicin

Interventions

ASC40DRUG

Oral tablets

Inducer groupInhibitor group
ItraconazoleDRUG

Oral capsules

Inhibitor group
rifampicinDRUG

Oral capsules

Inducer group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • kg/m2 ≤ BMI \<40kg/m2.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan provincial people's hospital

Changsha, Hunan, China

Location

MeSH Terms

Interventions

ItraconazoleRifampin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 13, 2021

Study Start

April 4, 2021

Primary Completion

May 6, 2021

Study Completion

May 14, 2021

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

CN(1)