Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients (DPM-PK-102)

Syntara

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Mannitol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00792714

DPM-PK-102

Details and patient eligibility

About

The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.

Enrollment

18 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have given written informed consent to participate in this study in accordance with local regulations
Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)
Be aged >6 years (6-11 for paediatrics, 12-17 for adolescents and 18 years for adults)
Have FEV1 > 30 % and < 90% predicted

Exclusion criteria

Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
Be considered "terminally ill" or listed for lung transplantation
Have had a lung transplant
Be using nebulised hypertonic saline
Have had a significant episode of haemoptysis (> 60 mL) in the three months prior to enrolment
Have had a myocardial infarction in the three months prior to enrolment
Have had a cerebral vascular accident in the three months prior to enrolment
Have had major ocular surgery in the three months prior to enrolment
Have had major abdominal, chest or brain surgery in the three months prior to enrolment
Have a known cerebral, aortic or abdominal aneurysm
Be breast feeding or pregnant, or plan to become pregnant while in the study
Be using an unreliable form of contraception (female patients at risk of pregnancy only)
Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry (except inhaled mannitol)
Not able to maintain a mannitol free diet from Day -2 until Day 8 of the treatment phase.
Have a known allergy to mannitol
Be using beta blockers
Have uncontrolled hypertension - systolic blood pressure > 190 and / or diastolic blood pressure > 100
Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
Be MTT positive.