NCT03903302

Study Investigation Pharmacokinetics and Pharmacodynamics of CS1

A Single Center, Randomised Study to Investigate Pharmacokinetics of CS1, Safety and Tolerability and in Obese, Borderline Hypertensive But Otherwise Healthy and Medicine Free Subjects After Administration of Single and Multiple Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cereno Scientific AB · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

SAD study: Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III. The result of the pharmacokinetics analysis from the 6 first subjects is defined as SAD Pilot and will be used to evaluate the timing of PK sampling. Based on pharmacokinetic evaluations from all 18 subjects one of the formulations I (275 mg), II (276 mg) or III (276 mg) will be chosen to proceed into the MAD study. If none of the formulations show the desired PK properties the formulations may be re-dosed with a slightly different timing of the dose, i.e the IMP to be administered earlier or later during the evening. MAD study: Fifteen subjects will be included in a dose escalating study with 2 dose levels. The subjects will receive the lowest dose level (275 or 276 mg depending on the outcome of SAD) for the first 2 weeks before the dose is doubled (550 or 552 mg depending on the outcome of SAD) for the following 2 weeks.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	CS1-Sodium Valproate	Single and multiple dose evaluation of CS1

Timeline

• Start date: 2017-10-06
• Primary completion: 2018-02-28
• Completion: 2018-03-27
• First posted: 2019-04-04
• Last updated: 2019-04-08

Locations

1 site across 1 country: Sweden