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Status unknownNCT00426920Updated Jan 25, 2007

Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

A Phase 1 interventional study of Insulin in Diabetes Mellitus, sponsored by QDose Limited. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-01-25.

Sponsored by QDose Limited · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Read the detailed description

Explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • pharmacokinetics
  • pharmacodynamics
  • inhaled
  • recombinant human insulin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with QDose Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • male
  • non smoking for at least 12 months
  • BMI equal to or less than 28
  • no clinically significant abnormalities
  • FVC and FEV1 equal to or more than 80%
  • willing to participate and to sign informed consent form

Exclusion criteria

Exclusion Criteria:

  • positive results for insulin antibodies at screening
  • history of substance abuse or dependency within last 5 years
  • positive screening test for substance abuse
  • positive blood test for HIV, hepatitis B or hepatitis C antibody
  • fasting blood glucose of more than 126mg/dl
  • any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
  • history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
  • has received investigational medications within 21 days prior to receiving the first dose of study medication
  • has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
  • has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
  • health that may be adversely affected by procedures or medications used in the study
  • unwillingness or inability to understand or to follow required study restrictions and procedures
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants

Interventions

  • DrugInsulin
06

What researchers measure

Primary outcomes

  1. maximum insulin serum concentration

  2. early T50%

  3. late T50%

  4. Tmax

  5. AUC

Secondary outcomes

  1. maximum glucose infusion rate

  2. early T50%

  3. late T50%

  4. Tmax

  5. AUC

07

Study locations

1 site
  • Profil Institute for Clinical Research Incorporated
    Chula Vista, California 91911, United States
    • Marcus hompesch, MD · Contact · 619-427-1300
    • 24-hour emergency number · Contact · 619-409-1277
    • Marcus Hompesch, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00426920
Lead sponsor
QDose Limited
First posted
Jan 25, 2007
Start date
Feb 2007
Last update
Jan 25, 2007

Study contacts

Marcus Hompesch, MD
Contact
619-427-1300
24-hour emergency number
Contact
619-409-1277
Marcus Hompesch, MD
principal investigator · Profil Institute for Clinical Research Incorporated
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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