Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

• Status: Completed
• Trial end date: 2019-08-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Collaborators: International Trial Expertise and Advisory Servies (ITREAS); Medpace, Inc.
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (PE) categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;

• Subjects must have a computed tomography angiography (CTA) scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;

• Subjects should be in otherwise satisfactory health in the opinion of the Investigator;

• Subjects must be able to provide written informed consent.

Exclusion Criteria:

• Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;

• Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;

• Subjects with PE lesions only in the sub-segmental or smaller arteries;

• Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with low molecular weight (LMW) Heparin in therapeutic doses prior to randomization;

• Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;

• Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;

• Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;

• Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);

• Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.