Randomized, double-blind (for clazosentan), placebo- and moxifloxacin-controlled, 3-way cross-over Phase 1 study to assess the effect of two intravenous doses of clazosentan on the QTc interval duration in healthy subjects

Randomized, double-blind (for clazosentan), placebo- and moxifloxacin-controlled, 3-way cross-over Phase 1 study to assess the effect of two intravenous doses of clazosentan on the QTc interval duration in healthy subjects - CS0297 (ID-054-107)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46268

Enrollment

Registered

2018-08-16

Start date

2018-09-18

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

cerebral vasospasm (cerebral hemorrhage)

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG,vital signs). Furthermore a blood a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female (non-childbearing potential) between 18 and 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.;Further inclusion criteria can be found in the protocol section 3.2.2.

Exclusion criteria

Exclusion criteria: 1. Previous exposure to clazosentan. 2. Previous exposure to Moxifloxacin within 3 months prior to Screening. 3. Known hypersensitivity to clazosentan or Moxifloxacin or treatments of the same class, or any of their excipients.;Further exclusion criteria can be found in the protocol section 3.2.3.

Design outcomes

Primary

Measure	Time frame
Cardiodynamic variables	—

Secondary

Measure	Time frame
pharmacokinetic parameters safety parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)