NCT01530464

The Safety Evaluation of Aminophylline and Ambrisentan When Administered Orally Alone and in Combination to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Thies Schroeder · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with the primary objective of testing the safety and tolerability of combined oral doses of aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when administered alone or in combination. It is hypothesized that the combination of these drugs is generally safe, and that no drug interaction can be observed.

Detailed description

This is a Phase I, three period, two sequence, single-center, open-label, randomized, crossover study design. Periods I and II consist of the oral administration of either a single dose of aminophylline or ambrisentan alone, followed by a 48 hour wash out interval. Subsequently, Period III consists of the simultaneous administration of both drugs. All subjects are to be confined to the Duke Clinical Research Unit throughout all treatment periods \[Study Day -1 to Study Day 6 (discharge)\]. A sufficient number of healthy adult subjects will be consented in order to enroll 24 and complete 16 subjects who complete all three periods. Replacement of subjects is permitted, if necessary. Qualified subjects will be randomized into one of two sequences consisting of three Periods as indicated below: -------------Period 1-----Period 2-----Period 3 Sequence A: Treatment 1 Treatment 2 Treatment 3 Sequence B: Treatment 2 Treatment 1 Treatment 3 TREATMENTS: Treatment 1: Aminophylline 500 mg (corresponding to 395 mg theophylline). Treatment 2: Ambrisentan 5 mg. Treatment 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg. After completion of each treatment period, the subjects will proceed to the next period provided no Stopping Rules criteria have been met

Conditions

• High Altitude Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Aminophylline	Drug will be administered as a single oral dose of 500mg, followed by a 48h washout period.
DRUG	Ambrisentan	Drug will be administered as a single dose of 5mg, followed by a 48h washout period
DRUG	Aminophylline plus ambrisentan	Drugs will be given as single doses of 500mg (aminophylline) and 5mg (ambrisentan), followed by a 48h washout period

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-02-10
• Last updated: 2014-01-16
• Results posted: 2014-01-16

Locations

1 site across 1 country: United States