A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.PART 1.

CPR Pharma Services0 sites73 target enrollmentMay 10, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: CPR Pharma Services
Enrollment: 73
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 10, 2013

End Date

July 14, 2015

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

CPR Pharma Services

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent must be obtained before any assessment is performed.
•2\. Healthy male and female (of non\-childbearing potential) subjects age 18 to 55 years in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
•a. Women are considered post\-menopausal and not of child bearing potential if they have had at least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels at the local laboratory levels for post\-menopause; or have had surgical bilateral oophorectomy or bilateral salpingectomy (with or without hysterectomy) at least six months ago. Women on oral contraceptives are to be excluded from the study, also women who have had a tubal ligation.
•3\. At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3\) minutes and again when required after three (3\) minutes in the standing position. Investigators can be guided by the following ranges:
•a. oral body temperature between 35\.0\-37\.5 degrees celcius
•b. systolic blood pressure, 90\-140 mm Hg
•c. diastolic blood pressure, 50\-90 mm Hg
•d. pulse rate, 40\-90 bpm
•4\. When blood pressure and pulse are taken after at least 3 minutes standing, there should be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (\>20 bpm) (compared to the sitting results) associated with clinical manifestation of postural hypotension. Any subject exhibiting clinical manifestations of postural hypotension should be excluded.
•5\. Must have haematology, clinical chemistry and urinalysis results at screening that are within the reference range or, if outside the range, not clinically significant as judged by the investigator and confirmed and agreed by the medical monitor; aspartate aminotransferase (AST), ALT and bilirubin must be within the reference range at screening

Exclusion Criteria

•1\. Known hypersensitivity to any of the study drugs.
•2\. Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half\-lives of enrolment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
•3\. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
•4\. A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at Screening or Baseline:
•a. PR \>210 msec
•b. QRS complex \>120 msec
•c. QTcF \>450 msec or shortened QTcF less than 340 msec or a family history of long QT syndrome or sudden death.
•d. Second or third degree atrioventricular block.
•e. Incomplete, full or intermittent bundle branch block.
•f. Abnormal T wave morphology.