A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001

NCT02386761 | Completed Phase 1

• 1 other identifier: CCD-06001AA1-08
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  0-14 days

Study Arms (2)

Single Ascending Dose (SAD)

EXPERIMENTAL

* Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg * Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg * Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period. In case the actual doses are modified, the number of inhalations will be adapted accordingly.

Drug: Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD)

EXPERIMENTAL

* Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo * Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo * Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo Duration 14 days b.i.d.

Drug: Multiple Ascending Dose (MAD)

Interventions

Single Ascending Dose (SAD) DRUG

Also known as: CHF6001

Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD) DRUG

Also known as: CHF6001

Multiple Ascending Dose (MAD)

Eligibility Criteria

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

You may not qualify if:

• Pregnant or lactating women
• Clinically significant cardiac abnormalities
• Any clinically relevant abnormal laboratory values

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Quotient Clinical

Nottingham, UK, NG116JS, United Kingdom

Location

Related Publications (2)

• Jolling K, Abelo A, Luyckx N, Nandeuil MA, Govoni M, Cella M, Lindauer A. Concentration-QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase-4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation. CPT Pharmacometrics Syst Pharmacol. 2019 Jul;8(7):460-468. doi: 10.1002/psp4.12405. Epub 2019 May 11.

  PMID: 31077576 BACKGROUND

• Mariotti F, Govoni M, Lucci G, Santoro D, Nandeuil MA. Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers. Int J Chron Obstruct Pulmon Dis. 2018 Oct 18;13:3399-3410. doi: 10.2147/COPD.S174156. eCollection 2018.

  PMID: 30425469 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tanimilast

Condition Hierarchy (Ancestors)

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

Study Officials

• Stuart Mair, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: March 12, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

GB (1)