Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLo… (NCT06492226) | Clinical Trial Compass
CompletedPhase 1
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
South Africa54 participantsStarted 2024-07-30
Plain-language summary
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Who can participate
Age range18 Years – 50 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant
âś“. Healthy male participants
âś“. Age between 18 and 50 years, both inclusive
âś“. Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
✓. Body weight ≥ 50 kg
✓. Fasting plasma glucose concentration ≤ 5.5 mmol/L at screening
âś“. Considered generally healthy upon completion of medical history, physical examination, vital signs, electrocardiogram (ECG), and analysis of laboratory safety variables, as judged by the Investigator
âś“. Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
Exclusion criteria
âś•. Positive for human insulin antibodies at Screening
âś•. Are currently enrolled in or have discontinued within 3 months or 5 half-lives (whichever is longer) of any investigational drug or device or are concurrently enrolled in any other type of medical research study and judged not to be scientifically or medically compatible with this study.
âś•. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
What they're measuring
1
Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).
Timeframe: Day 1 for 12 Hours
2
Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)
Timeframe: Day 1 for 12 Hours
3
Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).
âś•. History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
âś•. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
âś•. Have clinically relevant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data.
âś•. Increased risk of thrombosis, e.g., individuals with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
âś•. Clinically significant abnormal ECG at screening.