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

NCT00619346 | Terminated Phase 1

• 1 other identifier: C05-013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 - Day 42

Secondary Outcomes (1)

• 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.

  Screening, Day 7, Day 14, Day 21 and Day 42 of the study.

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

ACTIVE COMPARATOR

Pafuramidine maleate, 100 mg tablet, BID X 14 days

Drug: pafuramidine maleate

Interventions

Placebo DRUG

Placebo tablets, BID X 14 days

1

pafuramidine maleate DRUG

Pafuramidine maleate, 100 mg tablet BID X 14 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Immtech Pharmaceuticals, Inc: lead

Study Sites (1)

Farmovs-Parexel

Bloemfontein, Republic of South Africa, 9324, South Africa

Location

Study Officials

• Anina M Van der Bijil, MD

  Farmovs-Parexel Clinical Research Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

ZA (1)