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

Sponsored by:	Immtech Pharmaceuticals, Inc
Information provided by:	Immtech Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00619346

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Placebo Drug: pafuramidine maleate	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects

Further study details as provided by Immtech Pharmaceuticals, Inc:

Primary Outcome Measures:

The primary objective of this study is to establish the safety and tolerability profile of pafuramidine maleate 100 mg BID administered orally for 14 days to healthy subjects. [ Time Frame: Day 1 - Day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objective of this study is to evaluate the potential effect of pafuramidine maleate on specific analytes that can be assessed by clinical chemistry and hematology testing. [ Time Frame: Screening, Day 7, Day 14, Day 21 and Day 42 of the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	175
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablets resembling 100 mg tablet of active drug BID X 14 days	Drug: Placebo Placebo tablets, BID X 14 days
2: Active Comparator Pafuramidine maleate, 100 mg tablet, BID X 14 days	Drug: pafuramidine maleate Pafuramidine maleate, 100 mg tablet BID X 14 days

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619346

Locations

South Africa, Republic of South Africa
Farmovs-Parexel
Bloemfontein, Republic of South Africa, South Africa, 9324

Sponsors and Collaborators

Immtech Pharmaceuticals, Inc

Investigators

Principal Investigator:

Anina M Van der Bijil, MD

Farmovs-Parexel Clinical Research Organization

More Information

Responsible Party:	Immtech Pharmaceuticals, Inc. ( Carol Olson, MD, PhD/Sr. VP, Pharmaceutical Development & Chief Medical Officer )
Study ID Numbers:	C05-013
Study First Received:	February 8, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00619346
Health Authority:	United States: Food and Drug Administration

Keywords provided by Immtech Pharmaceuticals, Inc:

Safety
Tolerability
Assessment of potential adverse events and/or laboratory abnormalities

Study placed in the following topic categories:

Maleic acid
Healthy
Congenital Abnormalities

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009