A randomised, double-blind, placebo-controlled, single ascending dose/multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KBP-042 in healthy adult male volunteers.

A randomised, double-blind, placebo-controlled, single ascending dose/multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KBP-042 in healthy adult male volunteers. - FIH study of KBP-042.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42391

Enrollment

Registered

2015-03-03

Start date

2015-03-17

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 or multiple doses of KBP-042 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male subjects - 18-45 yrs, inclusive - BMI: 18-28 kglrn2, inclusive - Provision of written informed consent

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
Safety: lncidence and severity of adverse events, laboratory abnormalities, changes in ECGs and Vital signs	—

Secondary

Measure	Time frame
Pharmacokinetic endpoints Pharmacokinetic characteristics will be determined for KBP-042 following each treatment. They will be derived by non-compartmental analysis of the KBP-042 concentration-time data. Pharmacodynamic endpoints Part A - Serum C-terminal telopeptide, lactate, osteocalcin and calcium and fasting Plasma Glucose - oral glucose tolerance test (plasma glucose, insulin, glucagon, C-peptide and incretines) - Urine sodium, potassium, calcium, inorganic phosphate, creatinine, C-terminal telopeptide, N-terminal telopeptide Part B - Serum C-terminal telopeptide, lactate, osteocalcin and calcium and fasting Plasma Glucose - oral glucose tolerance test (plasma glucose, insulin, glucagon, C-peptide and incretines) - Urine sodium, potassium, calcium, inorganic phosphate, creatinine, C-terminal telopeptide, N-terminal telopeptide, - Vas Nausea, Hunger, Satiety, Wish to eat	—

Measure

Time frame

Pharmacokinetic endpoints Pharmacokinetic characteristics will be determined for KBP-042 following each treatment. They will be derived by non-compartmental analysis of the KBP-042 concentration-time data. Pharmacodynamic endpoints Part A - Serum C-terminal telopeptide, lactate, osteocalcin and calcium and fasting Plasma Glucose - oral glucose tolerance test (plasma glucose, insulin, glucagon, C-peptide and incretines) - Urine sodium, potassium, calcium, inorganic phosphate, creatinine, C-terminal telopeptide, N-terminal telopeptide Part B - Serum C-terminal telopeptide, lactate, osteocalcin and calcium and fasting Plasma Glucose - oral glucose tolerance test (plasma glucose, insulin, glucagon, C-peptide and incretines) - Urine sodium, potassium, calcium, inorganic phosphate, creatinine, C-terminal telopeptide, N-terminal telopeptide, - Vas Nausea, Hunger, Satiety, Wish to eat

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)