Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

NCT04739774 | Completed Phase 1

• 2 other identifiers: CLI-06001AA1-112020-003769-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter (Cmax)

  Peak Plasma Concentration (Cmax) for CHF6001

  Over 96 hours after administration in blood

• Pharmacokinetic parameter (AUCt)

  Area under the plasma concentration versus time curve (AUCt) for CHF6001

  Over 96 hours after administration in blood

Secondary Outcomes (7)

• Pharmacokinetic parameter (AUC0-96)

  Over 96 hours after administration in blood

• Pharmacokinetic parameter (AUC0-∞)

  Over 96 hours after administration in blood

• Pharmacokinetic parameter (tmax)

  Over 96 hours after administration in blood

• Pharmacokinetic parameter (t1/2)

  Over 96 hours after administration in blood

• Pharmacokinetic parameter (CL/F)

  Over 96 hours after administration in blood

Study Arms (2)

Treatment R

EXPERIMENTAL

Single dose of CHF6001

Drug: CHF6001 DPI

Treatment T

EXPERIMENTAL

Single dose of CHF6001 administered after repeated doses of oral Itraconazole

Drug: CHF6001 DPI; Drug: Itraconazole

Interventions

CHF6001 DPI DRUG

Single dose of CHF6001

Treatment R; Treatment T

Itraconazole DRUG

Repeated doses of oral Itraconazole

Treatment T

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject's written informed consent obtained prior to any study-related procedure;
• Healthy male and female subjects aged 18-55 years inclusive;
• Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient PIF using the In-Check device.
• Body Mass Index (BMI) between 18,0 and 35,0 kg/m2 extremes inclusive;
• Non- or ex-smokers who smoked \< 5 pack years and stopped smoking \> 1 year prior to screening;
• Good physical and mental status
• Vital signs within normal limits
• lead digitalized Electrocardiogram (12-lead ECG) considered as normal
• Pulmonary function test within normal limits
• Women of Childbearing Potential (WOCBP) with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method in addition to a barrier contraception method from the signature of the informed consent and until the follow-up visit. Males with non-pregnant WOCBP partners: they and or/ their partner must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until the follow-up visit. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until the follow-up visit

You may not qualify if:

• Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
• Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders, gastric surgery recent or in the past, and/or impaired gastric motility
• Clinically relevant abnormal laboratory values
• Abnormal liver enzymes at screening
• Subjects with history of breathing problems
• Positive HIV1 or HIV2 serology
• Positive results from the Hepatitis serology
• Blood donation or blood loss (equal or more than 450 ml) less than 2 months prior to screening or before the first dosing;
• Positive urine test for cotinine
• Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
• Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen
• Intake of non-permitted concomitant medications in the predefined period
• Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before the first dosing;
• Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
• Known allergy to antifungal medicines;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

SGS Life Sciences - Clinical Pharmacology Unit Antwerpen

Antwerp, 2060, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

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

Model Details: one sequence cross-over design

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: February 22, 2021
• Primary Completion: April 20, 2021
• Study Completion: April 26, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)