A Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers.

A Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers. - Exenatide Thorough QT study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43489

Enrollment

Registered

2016-01-07

Start date

2016-01-18

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

repolarisatie van het hart Cardiac repolarization

Interventions

Part A: The study will consist of 1 period during which 0.406 µg/kg exenatide will be given as a continuous IV infusion of 6 hours. For the second group the dose can be adjusted if the target exposu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy males and females -18 - 65 years old; -Body mass index (BMI) >=19.0 and

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Part A pilot: To determine if the infusion regimen of a 6-h continuous IV infusion of exenatide could lead to mean plasma concentration of 500 pg/mL at the end of the infusion. Part B: To evaluate whether exenatide at therapeutic and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization, as detected by changes in the QTc interval, that reaches the ICH E14 threshold.	—

Measure

Time frame

Part A pilot: To determine if the infusion regimen of a 6-h continuous IV infusion of exenatide could lead to mean plasma concentration of 500 pg/mL at the end of the infusion. Part B: To evaluate whether exenatide at therapeutic and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization, as detected by changes in the QTc interval, that reaches the ICH E14 threshold.

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Secondary

Measure	Time frame
Part A Pilot: -To evaluate the safety, tolerability and PK of a 6 h continuous IV infusion of exenatide Part B: -To evaluate the relationship between plasma concentrations of exenatide and QTc interval. -To evaluate the effects of exenatide on other cardiac intervals such as PR, RR, QRS, QT, T- and U- wave morphology. -To assess the assay sensitivity to detect a change in the QTc interval, using 400 mg moxifloxacin as the active control. -To evaluate the safety, tolerability and PK of a 6 h continuous IV infusion of exenatide.	—

Measure

Time frame

Part A Pilot: -To evaluate the safety, tolerability and PK of a 6 h continuous IV infusion of exenatide Part B: -To evaluate the relationship between plasma concentrations of exenatide and QTc interval. -To evaluate the effects of exenatide on other cardiac intervals such as PR, RR, QRS, QT, T- and U- wave morphology. -To assess the assay sensitivity to detect a change in the QTc interval, using 400 mg moxifloxacin as the active control. -To evaluate the safety, tolerability and PK of a 6 h continuous IV infusion of exenatide.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)