A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects

NCT00446771 | Completed Phase 1

• 1 other identifier: DPM-PK-101
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• To determine the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously.

• To determine the relative bioavailability of mannitol powder for inhalation by comparison to orally administered mannitol.

• To determine the pharmacokinetic parameters of systemically available mannitol after administration of mannitol powder by inhalation.

Secondary Outcomes (1)

• A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.

Interventions

Mannitol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed a written informed consent form.
• Subject is a normal male volunteer between 18 and 65 years of age.
• Subject is willing to comply with the procedures of the study and to remain in the clinical unit for the scheduled visits.
• Subject is willing to abstain from chewing gum for the duration of the study.

You may not qualify if:

• Subject has asthma or other disease affecting the lungs or airways.
• Subject has a history indicating possible airway hyperresponsiveness.
• Subject is allergic to mannitol or gelatin or a known intolerance to intravenous mannitol.
• Subject uses inhaled drugs (legal or illegal).
• Subject uses oral bronchodilator drugs.
• Subject has celiac disease, Crohn's disease or other disease affecting intestinal absorption.
• Subject has renal impairment or other condition that would affect urine collection.
• Subject's weight deviates by more than 15% from the ideal weight listed for his height in the Metropolitan Life table.
• Subject is a smoker.
• Subject has participated in another clinical trial within the past 30 days.
• Subject has used chewing gum within the past 72 hours.
• Subject needs to use bisphosphonates, non-steroidal anti-inflammatory agents, or other drugs known to affect intestinal permeability on a chronic basis.
• Subject has used non-steroidal anti-inflammatory agents within the past 72 hours

Sponsors & Collaborators

• Syntara: lead

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Andrew Humberstone

  Nucleus Networks

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: October 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 13, 2007

Record last verified: 2007-03