NCT05699993

Brief Summary

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

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

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 17, 2023

Last Update Submit

October 23, 2023

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

  • maximum concentrations (Cmax ) for IBI351

    approximately 10 days

  • maximum concentrations (Cmax ) for dextromethorphan

    approximately 10 days

  • area under the curve from time 0 to infinity(AUC0-inf) for IBI351

    approximately 10 days

  • area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan

    approximately 10 days

Secondary Outcomes (17)

  • time-to-maximum concentration (Tmax) for IBI351

    approximately 10 days

  • half-life (t1/2) for IBI351

    approximately 10 days

  • area under the curve from time 0 to time (AUC0-t) for IBI351

    approximately 10 days

  • apparent clearance (CL/F) for IBI351

    approximately 10 days

  • apparent volume of distribution(Vz/F) for IBI351

    approximately 10 days

  • +12 more secondary outcomes

Study Arms (2)

IBI351+ itraconazole

OTHER

Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal.

Drug: ItraconazoleDrug: IBI351

IBI351+ dextromethorphan

OTHER

Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later.

Drug: IBI351Drug: Dextromethorphan

Interventions

ItraconazoleDRUG

Itraconazole was administered orally

IBI351+ itraconazole
IBI351DRUG

IBI351 was administered orally

IBI351+ dextromethorphanIBI351+ itraconazole
DextromethorphanDRUG

Dextromethorphan was administered orally

IBI351+ dextromethorphan

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
  • Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
  • Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \~ 26 kg/m2 (including both ends).
  • Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

You may not qualify if:

  • have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
  • hepatitis B surface antigen HBsAg positive.
  • hepatitis C virus antibody positive.
  • positive AIDS antigen/antibody or Treponema pallidum antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

ItraconazoleDextromethorphan

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

March 10, 2023

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

CN(1)