Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00940329
First received: July 3, 2009
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography, ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed potential pharmacodynamic interactions. In addition, the safety and tolerability were evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and formoterol.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Roflumilast |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigation on the Cardiovascular and Pharmacokinetic Interaction Between Oral Roflumilast and Inhaled Formoterol in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Nycomed: A Takeda Company:
Primary Outcome Measures:
- Potential cardiovascular interaction (exploratory)
Secondary Outcome Measures:
- Potential pharmacokinetic interactions and potential pharmacodynamic interactions
- Safety and tolerability of the monotreatments and the combination treatment (exploratory)
| Enrollment: | 27 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Treatment A |
Drug: Roflumilast
Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)
|
| Active Comparator: Treatment B |
Drug: Roflumilast
Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age between 18 and 45 years
- Normal body weight as indicated by a Body Mass Index (BMI) between 18 and 30 kg/m2 and a body weight > 50 kg
- Assessed as healthy, based on a screening examination including medical history, physical examination, BP, PuR, ECG, and clinical laboratory results
- Caucasian
Exclusion Criteria:
- Suspected lack of compliance
- Participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study)
- Any active disease, acute or chronic (also psychiatric diseases)
- Any signs or present history of cardiac diseases (e.g. QTc interval acc. to Bazett ≥ 430 ms, PQ ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree AV-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia
- Proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by SBP < 90 mm Hg (standing blood pressure, 30 s after raising up from a supine position)
- Gastrointestinal surgery except from appendectomy and herniotomy
- HIV or hepatitis screening positive or not performed (in case of a positive HIV test, the subject had to be informed by a physician in personal communication
- Drug screening positive or not performed
- Excessive xanthine consumption (more than 5 cups of coffee or equivalent per day)
- Non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)
Contacts and Locations More Information
No publications provided by Nycomed: A Takeda Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head of Exploratory Clinical Development, Nycomed GmbH |
| ClinicalTrials.gov Identifier: | NCT00940329 History of Changes |
| Other Study ID Numbers: | BY217/CP-059 |
| Study First Received: | July 3, 2009 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Nycomed: A Takeda Company:
|
Drug interactions Pharmacodynamic interactions Pharmacokinetic interactions Formoterol |
Healthy subjects Phase I study Roflumilast |
Additional relevant MeSH terms:
|
Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013