TRIPLE 1: Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

• Sponsor: Chiesi Farmaceutici S.p.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01398111
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 14.6

Study Details

Study Description

Brief Summary

This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Glycopyrrolate + Formoterol; Drug: Glycopyrrolate; Drug: Formoterol; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment R2	Drug: Formoterol; formoterol pMDI
Active Comparator: Treatment R1	Drug: Glycopyrrolate; glycopyrrolate pMDI
Placebo Comparator: Placebo	Drug: Placebo; placebo pMDI
Experimental: Treatment T	Drug: Glycopyrrolate + Formoterol; glycopyrrolate pMDI + formoterol pMDI

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: formoterol and glyco AUC0-t [from pre-dose to 32 hours after administration]

   Area under the plasma concentration curve observed from administration up to the last measurable concentration.

2. Pharmacokinetics: formoterol and glyco Cmax [from pre-dose to 32 hours after administration]

   Maximum plasma concentration

Secondary Outcome Measures

1. Additional pharmacokinetic variables [from pre-dose to 32 hours post dose]

   Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.

2. Serum potassium [From pre-dose to 24 hours after administration]

   Serum potassium Cmin, tmin and AUC0-24h

3. Plasma glucose [from pre-dose to 24 hours after administration]

   Plasma glucose Cmax, tmax and AUC0-24h

4. Lung function [from pre-dose to 1 hour after administration]

   FEV1 in order to assess potential occurrence of paradoxical bronchospasm

5. Vital signs [from pre-dose to 24 hours after administration]

   heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).

6. ECG [from pre-dose to 24 hours after administration]

   12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Males and females healthy volunteers aged 18-65 years will be included in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology Unit - SGS Life Science Services	Antwerpen	Lange Beeldekensstraat 267	Belgium	2060

Sponsors and Collaborators

• Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Lien Gheyle, MD, Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CSR Synopsis available in the Chiesi Clinical Study Register

Publications

None provided.

• Responsible Party: Chiesi Farmaceutici S.p.A.
• ClinicalTrials.gov Identifier: NCT01398111
• Other Study ID Numbers: CCD-1101-PR-0056; 2011-001552-11
• First Posted: Jul 20, 2011
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Glycopyrrolate; Formoterol Fumarate

Study Results

No Results Posted as of Oct 29, 2021