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A Study in Healthy People to Measure How Different Doses of Verducatib Affect the Heart

Not Yet RecruitingPhase 1

Sponsor: Boehringer Ingelheim

Conditions: Healthy

Interventions: Verducatib, Moxifloxacin, Placebo resembling Verducatib, Placebo resembling Moxifloxacin

Countries: Germany

The main objective of this trial is to evaluate the effects of verducatib in the range of therapeutic to supra-therapeutic exposures on the QT/QTc-interval and other ECG parameters

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Healthy male and female trial participants
2. Aged 18 to 50 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination, including blood pressure (BP), heart rate (HR) or electrocardiogram (ECG), deviating from normal and assessed as clinically relevant by the Investigator
2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, including but not limited to increased hepatic parameters, electrolyte disturbances, particularly hypokalemia and hypomagnesemia
4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator Further exclusion criteria apply.

Locations (1)

Mannheim, Germany