A Randomised, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KBP-089 in Healthy Adult Male Volunteers

A Randomised, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KBP-089 in Healthy Adult Male Volunteers - FIH study of KBP-089

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43278

Enrollment

Registered

2016-07-26

Start date

2016-10-21

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult-onset diabetes type 2 diabetes mellitus

Interventions

Single dose KBP-089 or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male subjects, 18-45 years of age, inclusive 2. Body mass index (BMI) *18.0 and

Exclusion criteria

Exclusion criteria: Any clinically significant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. Positive test at screening of any of the following: Hepatitis B, Hepatitis C or human immunodeficiency virus/AlDS.

Design outcomes

Primary

Measure	Time frame
Tolerability / safety endpoints - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Clinical laboratory tests (haematology, chemistry (including cortisol and aldosterone) and urinalysis) - Vital signs (pulse rate, systolic blood pressure, diastolic blood pressure and body temperature) - Electrocardiogram (12 lead ECG) (heart rate (HR), PR, QRS, QT, QTc)	—

Secondary

Measure	Time frame
Pharmacokinetic endpoints The following endpoints will be determined for KBP-089 following each treatment. They will be derived by non-compartmental analysis of the KBP-089 concentration-time data: - The area under the concentration-time curve from zero to infinity (AUC0-inf); - The maximum concentration (Cmax); - The area under the concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last); - The time to reach maximum plasma concentration (tmax); - The terminal disposition rate constant (z) with the respective half-life (t). - Other parameters, including Vz/F, CL/F, and other parameters as appropriate, as well as dose adjusted parameters, may be determined. Pharmacodynamic endpoints - Serum CTX, osteocalcin and calcium assessed at baseline, t=15 and 30 min, 1, 2, 3, 4, 8 and 24 h after dosing - Blood sampling for electrolytes, ACTH, PTH, renin and creatinine at baseline, t=4, 8, 12 and 24 h after dosing - Fasting glucose assessed at baseline, t=30, 60, 90 and 120 min after dosing - Glucose, insulin, glucagon, C-peptide and incretines (GLP1, GIP) after snack at t=150, 180 and 210 min - Glucose, insulin, glucagon, C-peptide and incretines (GLP1, GIP) at baseline and at 0, 30, 60, 90, 120 and 180 minutes after standard meal ingestion (which is 4 h after dosing) - VAS Nausea, Hunger, Fullness, Wish to eat at baseline and during the first 8 h after dosing every 30 min, 10 and 12 h after drug administration - Urine sodium, potassium, calcium, inorganic phosphate, creatinine for 24 h after drug administration (in 3 portions; 0-6 h, 6-12 h, and 12-24 hours)	—

Measure

Time frame

Pharmacokinetic endpoints The following endpoints will be determined for KBP-089 following each treatment. They will be derived by non-compartmental analysis of the KBP-089 concentration-time data: - The area under the concentration-time curve from zero to infinity (AUC0-inf); - The maximum concentration (Cmax); - The area under the concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last); - The time to reach maximum plasma concentration (tmax); - The terminal disposition rate constant (*z) with the respective half-life (t*). - Other parameters, including Vz/F, CL/F, and other parameters as appropriate, as well as dose adjusted parameters, may be determined. Pharmacodynamic endpoints - Serum CTX, osteocalcin and calcium assessed at baseline, t=15 and 30 min, 1, 2, 3, 4, 8 and 24 h after dosing - Blood sampling for electrolytes, ACTH, PTH, renin and creatinine at baseline, t=4, 8, 12 and 24 h after dosing - Fasting glucose assessed at baseline, t=30, 60, 90 and 120 min after dosing - Glucose, insulin, glucagon, C-peptide and incretines (GLP1, GIP) after snack at t=150, 180 and 210 min - Glucose, insulin, glucagon, C-peptide and incretines (GLP1, GIP) at baseline and at 0, 30, 60, 90, 120 and 180 minutes after standard meal ingestion (which is 4 h after dosing) - VAS Nausea, Hunger, Fullness, Wish to eat at baseline and during the first 8 h after dosing every 30 min, 10 and 12 h after drug administration - Urine sodium, potassium, calcium, inorganic phosphate, creatinine for 24 h after drug administration (in 3 portions; 0-6 h, 6-12 h, and 12-24 hours)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)