Healthy SubjectsPhase 1NCT00721344
A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.
A Phase 1 study testing Technosphere Inhalation Powder (FDKP) and Moxifloxacin in people with Healthy Subjects, run by Mannkind Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Technosphere Inhalation Powder (FDKP) and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
- Unwillingness to remain in a quiet, controlled environment (i.e., no TV, music, games, etc during specific timepoints) or unwilling to remain supine during specific timepoints
- Unwillingness to consume a study-specific diet
- Blood donation within 8 weeks prior to Visit 2
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiological finding
- Active respiratory infection or persistent symptoms of such infection
- History of risk factors for Torsades de pointes (TdP) [e.g., heart failure, hypokalemia, family history (parents or siblings) of Long QT Syndrome], history of fainting, unexplained loss of consciousness or convulsions
- History of cardiac arrhythmia, of taking anti-arrhythmia drugs, significant cardiovascular dysfunction, myocardial dysfunction, cardiac surgery, transient attacks of ischemia or cerebrovascular accidents
- An abnormal screening ECG which is interpreted by the Clinical Site Investigator to be clinically significant
- Sustained supine resting systolic blood pressure > 140 mm Hg or < 100 mm Hg and /or diastolic blood pressure >95 mm Hg at study entry Baseline pulse rate of < 45 beats per minute or > 100 beats per minute
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Services Northwest
Tacoma, Washington, 98418
About this study
Official title: A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder in Healthy Subjects
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.
Read the detailed description
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
- Conditions
- Healthy Subjects
- Being tested
- Technosphere Inhalation Powder (FDKP), Moxifloxacin, Placebo
- Keywords
- Healthy males and females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere Inhalation Powder (FDKP)Drug
Technosphere® Inhalation Powder 20mg
MoxifloxacinDrug
Tablets 400mg
Technosphere Inhalation Powder (FDKP)Drug
Technosphere® Inhalation Powder 40mg
PlaceboDrug
Placebo cartridges
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo |
| 3 | Experimental | Not described Receives: Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo |
| 4 | Experimental | Not described Receives: Drug: Technosphere Inhalation Powder (FDKP); Drug: Moxifloxacin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 11 Days
Change in ECG morphological patterns
Measured: 11 Days
Heart rate and RR interval.
Measured: 11 Days
PR interval.
Measured: 11 Days
QRS interval.
Measured: 11 Days
Correlation between the QTcI change from baseline and plasma concentrations of FDKP.
Measured: 11 Days
Plasma concentrations of FDKP.
Measured: 11 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721344
- Sponsor's protocol ID
- MKC-T-131
- Status last verified
- Jun 2012
- First submitted
- 22 Jul 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00721344
- Acronym / sponsor ID
- MKC-T-131
- Conditions
- Healthy Subjects
- Keywords
- Healthy males and females
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technosphere Inhalation Powder (FDKP)Technosphere® Inhalation Powder 20mg | Drug | 1, 2, 3, 4 |
| MoxifloxacinTablets 400mg | Drug | 1, 2, 3, 4 |
| Technosphere Inhalation Powder (FDKP)Technosphere® Inhalation Powder 40mg | Drug | 1, 2, 3, 4 |
| PlaceboPlacebo cartridges | Drug | 1, 2, 3, 4 |
Primary outcome
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
Time frame: 11 days
9 secondary outcomes
The time-matched change from baseline in QTc after therapeutic dose Technosphere® Inhalation Powder based on an individual correction (QTcI) method.
Time frame: 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.
Time frame: 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.
Time frame: 11 Days
Change in ECG morphological patterns
Time frame: 11 Days
Heart rate and RR interval.
Time frame: 11 Days
PR interval.
Time frame: 11 Days
QRS interval.
Time frame: 11 Days
Correlation between the QTcI change from baseline and plasma concentrations of FDKP.
Time frame: 11 Days
Plasma concentrations of FDKP.
Time frame: 11 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technosphere Inhalation Powder (FDKP) and Moxifloxacin in people with Healthy Subjects, run by Mannkind Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.