A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.

NCT00721344 | Completed Phase 1

• 1 other identifier: MKC-T-131
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

48 healthy adult male \& female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible subjects will be randomized into a dosing regimen after admission.

Conditions

Healthy Subjects

Keywords

Healthy males and females

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder

  11 days

Secondary Outcomes (9)

• The time-matched change from baseline in QTc after therapeutic dose Technosphere® Inhalation Powder based on an individual correction (QTcI) method.

  11 days

• The maximum change in time-matched, placebo-subtracted QT interval corrected by Fridericia formula (QTcF) and Bazett formula (QTcB), respectively, for supratherapeutic dose of Technosphere® Inhalation Powder.

  11 Days

• The maximum change in time-matched, placebo-subtracted QT/QTc intervals by Fridericia formula (QTcF), and by Bazett formula (QTcB), respectively, for therapeutic dose of Technosphere® Inhalation Powder.

  11 Days

• Change in ECG morphological patterns

  11 Days

• Heart rate and RR interval.

  11 Days

Study Arms (4)

1

EXPERIMENTAL

Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo

2

EXPERIMENTAL

Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo

3

EXPERIMENTAL

Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo

4

EXPERIMENTAL

Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo

Interventions

Technosphere Inhalation Powder (FDKP) DRUG

Technosphere® Inhalation Powder 20mg

1; 2; 3; 4

Moxifloxacin DRUG

Tablets 400mg

1; 2; 3; 4

Placebo DRUG

Placebo cartridges

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pulmonary Function Tests (PFTs) results within study specified limits.
• Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
• Body Mass Index = 19 and = 30 kg/m2
• Absence of recent drug or alcohol abuse
• Able to provide written informed consent, follow study procedures and remain in-patient for the entire treatment period
• Non-smoking (\> 6 months)

You may not qualify if:

• History of significant renal, pulmonary, rheumatological, hematological, neurological or psychiatrics disorder
• Clinically significant major organ disease
• Evidence or history of clinically significant allergies (except for untreated, asymptomatic, seasonal allergies at time of dosing);
• Current or previous chemotherapy or radiation therapy that could cause lung toxicity
• History of diabetes or taking any medications to treat diabetes
• Clinically significant abnormal findings on physical exam, ECG, vital signs, clinical laboratory testing and medical history
• Hypokalemia (calcium below lower limit of normal).
• Previous exposure to Technosphere® Inhalation Powder
• Participation in another clinical trial of an investigational drug or device within 30 days prior to Visit 3
• Significantly excessive consumption of food or beverages with xanthine or caffeine
• Unwilling to avoid alcohol 48 hours prior to study enrollment and during study
• Unwilling to avoid strenuous activity for 48 hours prior to study enrollment and during study
• Positive HIV or Hepatitis test
• Any acute illness or fever within 72 hours of study dosing
• Medication use (with exception of acetaminophen and hormonal birth control) or herbal use within 7 days of Visit 2

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Charles River Clinical Services Northwest

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

3,6-bis(N-fumaryl-N(n-butyl)amino)-2,5-diketopiperazine; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

US (1)