NCT03209648

Brief Summary

Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2017

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

Study Start

First participant enrolled

June 14, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

July 4, 2017

Last Update Submit

October 17, 2017

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Plasma Concentration (Cmax) of Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

  • Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

  • Area Under the Plasma Concentration-time Curve from Time Zero to Time (t) (AUC0-t) of Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

Secondary Outcomes (14)

  • Area Under the Plasma Concentration-time Curve from Time Zero to 12 Hours Postdose (AUC0-12) of Debio 1452, Debio 1450, Debio 1452-M1, and desmethyl Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

  • Time to Reach Maximum Concentration (Tmax) of Debio 1452, Debio 1450, Debio 1452-M1, desmethyl Debio 1452 and Itraconazole

    Debio 1450 and its metabolites: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose. Itraconazole: Days 1, 3, and 6: predose, Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose

  • Apparent Plasma Terminal Elimination Half-life (t1/2) of Debio 1452, Debio 1450, Debio 1452-M1, desmethyl Debio 1452 and Itraconazole

    Debio 1450 and its metabolites: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose. Itraconazole: Days 1, 3, and 6: predose, Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose

  • Mean Residence Time (MRT) of Debio 1452, Debio 1450, Debio 1452-M1, and desmethyl Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

  • Apparent Total Body Clearance of a Drug from the Plasma (CL/F) of Debio 1452

    Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose

  • +9 more secondary outcomes

Study Arms (1)

Debio 1450

EXPERIMENTAL

In Treatment Period 1, participants will receive single oral dose of Debio 1450 40 mg on Day 1. In Treatment Period 2, participants will receive itraconazole 200 mg, twice daily (BID) orally, on Day 1, followed by itraconazole 200 mg once daily (QD), on Days 2 to 4, and then single oral dose of Debio 1450 40 mg and itraconazole 200 mg on Day 5, followed by a single oral dose of itraconazole 200 mg on Days 6 and 7.

Drug: Debio 1450Drug: Itraconazole

Interventions

Debio 1450DRUG

Debio 1450, 40 mg capsule.

Debio 1450
ItraconazoleDRUG

Itraconazole, 20 mL of 10 mg/mL solution.

Debio 1450

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets protocol-specified criteria for qualification and contraception.
  • Is willing and able to comply with restrictions related to food, drink and medications.
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures.

You may not qualify if:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters.
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff.
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); the analysis of results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

afabicinItraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

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

July 4, 2017

First Posted

July 6, 2017

Study Start

June 14, 2017

Primary Completion

August 23, 2017

Study Completion

August 31, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

GB(1)