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Completed

NCT Number: NCT02040597

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.

The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biovirtus Research Site, Nadarzyn, Mokra 7, Poland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers and
  • Subjects with mild, moderate and severe renal impairment

Exclusion criteria

  • pregnant or lactating women
  • positive HIV and hepatitis serology
  • history of drug abuse
  • history of hypersensitivity to the products used in the trial
  • smokers
  • respiratory disease such as asthma and COPD
  • clinically relevant concomitant disease that may introduce a risk for the subjects'safety
  • presence of kidney stones
  • dialysis

Treatment and study plan

Beclometasone/formoterol/glycopyrrolate

Drug

Other names: CHF 5993 pMDI

Primary outcomes

  1. Glycopyrrolate area under the curve (AUC)

    Time frame: over 72 h after single administration

    AUC until the last quantifiable concentration (AUCt)

Secondary outcomes

  1. Glycopyrrolate other Pharmacokinetic parameters in plasma

    Time frame: Over 72 h after single administration

    AUC until 72 h post dose (AUC0-72h), AUC extrapolated to infinity (AUCinf), maximum plasma concentratio (Cmax), time to maximum plasma concentration (tmax), half-life, clearance

  2. B17MP and Formoterol pharmacokinetic parameters in plasma

    Time frame: over 24 h after single administration

    AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance

  3. BDP pharmacokinetic parameters in plasma

    Time frame: over 24 h after single administration

    AUCt, AUCinf, Cmax, tmax, half-life

  4. Urine Glycopyrrolate excretion (Ae)

    Time frame: over 72 h after single administration

  5. Urine formoterol excretion (Ae)

    Time frame: Over 24 h after single administration

  6. Adverse events

    Time frame: A period of 3 to 7 weeks (from screening visit to follow-up phone call)

    This includes a period of 3 to 7 weeks (depending on duration of screening and follow-up periods), before and after the study drug administration

  7. Vital signs

    Time frame: over 24 h after single administration

    systolic and diastolic blood pressure

  8. Electrocardiogram (ECG) parameters

    Time frame: over 24 h after single administration

    Heart rate (HR), time interval between ECG waves Q and T corrected for heart rate with Fridericia's formula (QTcF), time interval between the onset of the ECG wave P and the start of the QRS complex (PR), time interval between the beginning of Q wave and the termination of the S wave (QRS)

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.

Acronym: TRIPLE10

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 20, 2014
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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