Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects

NCT ID: NCT00619346

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-02-28

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 criteria will be randomized in a 4:1 fashion to receive either pafuramidine maleate 100 mg tablets or matching placebo tablets administered twice daily for 14 days.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo tablets resembling 100 mg tablet of active drug BID X 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets, BID X 14 days

2

Pafuramidine maleate, 100 mg tablet, BID X 14 days

Group Type: ACTIVE_COMPARATOR

pafuramidine maleate

Intervention Type: DRUG

Pafuramidine maleate, 100 mg tablet BID X 14 days

Interventions

Placebo

Placebo tablets, BID X 14 days

Intervention Type: DRUG

pafuramidine maleate

Pafuramidine maleate, 100 mg tablet BID X 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female volunteers a minimum of 18 years to 75 years of age

2. 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.

3. 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

4. The subject has provided written informed consent prior to admission into this study.

Exclusion Criteria

1. 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

2. History of drug or alcohol abuse, (* 10 drinks weekly)

3. Blood donation within 30 days prior to dosing

4. History of drug allergies, anaphylaxis or laryngeal edema

5. Use of any medication within 7 days before dosing with study medication or anticipated need for any medication during the study conduct

6. 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

7. Clinically significant abnormal laboratory value at screening including CBC, blood chemistry or urinalysis

8. Clinically significant anomalies noted on physical examination or ECG

9. Resting pulse rate of > 100 beats per minute or < 45 beats per minute during the screening period, either supine or standing.

10. Any condition, which compromises ability to give informed consent or to communicate with the Investigator as required for the completion of this study

11. The subject has been previously enrolled in this study. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Immtech Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anina M Van der Bijil, MD

Role: PRINCIPAL_INVESTIGATOR

Farmovs-Parexel Clinical Research Organization

Locations

Farmovs-Parexel

Bloemfontein, Republic of South Africa, South Africa

Countries

South Africa

Other Identifiers

C05-013

Identifier Type: -

Identifier Source: org_study_id