A randomized, double-blind, placebo and positive controlled, parallel group study to investigate the QTc exposure response, pharmacokinetics, safetyand tolerability after multiple therapeutic and supratherapeutic dosing of etrasimod (APD334) in healthy adult subjects

A randomized, double-blind, placebo and positive controlled, parallel group study to investigate the QTc exposure response, pharmacokinetics, safetyand tolerability after multiple therapeutic and supratherapeutic dosing of etrasimod (APD334) in healthy adult subjects - APD334 QTc, safety and PK study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44472

Enrollment

Registered

2017-05-31

Start date

2017-05-24

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

autoimmune diseases

Interventions

The study will consist of a period of approximately 2 * weeks during which the volunteer will receive either multiple oral doses of etrasimod for 14 days (Treatment A) or a single dose of moxifloxac

APD334

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - healthy male/female subjects - 18-55 yrs, inclusive - BMI: 18.5-30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study or being a blood donor within 60 days from the start of the study. In case of donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first drug administration in the current study.

Design outcomes

Primary

Measure	Time frame
Change-from-baseline QTc (*QTc) with the selected primary correction method.	—

Secondary

Measure	Time frame
Change-from-baseline HR (*HR), QTc with the correction methods not selected as primary, PR, QRS, RR, and QT; Placebocorrected change-from-baseline HR, QTcF, QTcS, QTcI, QTcP, PR, QRS,RR, and QT; Categorical outliers for QTc, HR, PR, and QRS; Frequency of T-wave morphology and U-wave presence changes.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)