Status:
TERMINATED
Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects
Lead Sponsor:
Immtech Pharmaceuticals, Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1 study to establish the safety and tolerability profile of pafuramidine maleate 100 mg BID administered orally for 14 days to healthy subjects
Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel treatment single center safety and tolerability study. Subjects who meet all inclusion criteria and none of the exclusion crit...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers a minimum of 18 years to 75 years of age
- Female must be non-lactating and either be of non-child-bearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation) or if of child-bearing potential, must have a negative human chorionic gonadotropin (hCG) pregnancy test and be practicing effective dual barrier contraceptive method from consent to 42 days after initiation of study drug administration.
- Negative test for hepatitis B surface antigen, Hepatitis C antibody and HIV 1 and 2 antibody within 14 days prior to admission to this study
- The subject has provided written informed consent prior to admission into this study.
Exclusion
- History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically-mediated disorders
- History of drug or alcohol abuse, (\* 10 drinks weekly)
- Blood donation within 30 days prior to dosing
- History of drug allergies, anaphylaxis or laryngeal edema
- Use of any medication within 7 days before dosing with study medication or anticipated need for any medication during the study conduct
- Use of any investigational medication within 6 weeks prior to dosing with study medication or scheduled to receive an investigational drug other than pafuramidine maleate during the course of this study
- Clinically significant abnormal laboratory value at screening including CBC, blood chemistry or urinalysis
- Clinically significant anomalies noted on physical examination or ECG
- Resting pulse rate of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing.
- Any condition, which compromises ability to give informed consent or to communicate with the Investigator as required for the completion of this study
- The subject has been previously enrolled in this study. -
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00619346
Start Date
November 1 2007
End Date
February 1 2009
Last Update
March 7 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Farmovs-Parexel
Bloemfontein, Republic of South Africa, South Africa, 9324