A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenous CMX-020 in healthy male and female subjects

Phase 1

Completed

• Conditions: Pain Control; Anaesthesiology - Pain management

• Registration Number: ACTRN12617001583336
• Lead Sponsor: Cytometix Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

To qualify for enrollment in this study, the subject must satisfy the following inclusion criteria:
• Healthy adult male or adult female between the ages of 18-50 years in good physical health.
• Of non-childbearing potential or using an acceptable form of contraception
• Weigh at least 50 kg, and no more than 90and have a body mass index (BMI) between 18 and 32 kg/m2
• Clinical laboratory results (including clinical chemistry, hematology, and urinalysis) within the reference range for the testing laboratory
• Negative tox, hepatitis and HIV screens
• Creatinine clearance of at least 70 mL/min

Exclusion Criteria

Any subject who meets any of the following criteria will not qualify for entry into the study:
• History of drug abuse, cancer, liver disease, seizure, metabolic disease or head trauma
• Systolic blood pressure > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure > 90 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods
• Pulse > 100 beats/minute or < 50 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods
• Pulse oximetry values <95% on room air; temperature <35.8°C and >37.5°C
• Clinically significant abnormal ECG at Pretreatment Screening or Baseline/Check-in Periods or history of Long QT Syndrome
• Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
• Recent use of alcohol, tobacco, prescription or OTC medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified