HealthyPhase 1NCT00619346
Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects
A Phase 1 study testing pafuramidine maleate in people with Healthy, run by Immtech Pharmaceuticals, Inc at 1 site in South Africa.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pafuramidine maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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. -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Farmovs-Parexel
Bloemfontein, Republic of South Africa, 9324
About this study
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
Read the 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
- Being tested
- Placebo, pafuramidine maleate
- Keywords
- Safety, Tolerability, Assessment of potential adverse events and/or laboratory abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablets, BID X 14 days
pafuramidine maleateDrug
Pafuramidine maleate, 100 mg tablet BID X 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablets resembling 100 mg tablet of active drug BID X 14 days Receives: Drug: Placebo |
| 2 | Active comparator | Pafuramidine maleate, 100 mg tablet, BID X 14 days Receives: Drug: pafuramidine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Screening, Day 7, Day 14, Day 21 and Day 42 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: FDA Full Clinical Hold due to safety concerns, as of 12/21/07
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immtech Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anina M Van der Bijil, MD, Principal investigator, Farmovs-Parexel Clinical Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619346
- Sponsor's protocol ID
- C05-013
- Status last verified
- Mar 2013
- First submitted
- 8 Feb 2008
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00619346
- Acronym / sponsor ID
- C05-013
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Assessment of potential adverse events and/or laboratory abnormalities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Full Clinical Hold due to safety concerns, as of 12/21/07
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Immtech Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo tablets resembling 100 mg tablet of active drug BID X 14 days |
| 2 | Active comparator | Drug: pafuramidine maleatePafuramidine maleate, 100 mg tablet, BID X 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo tablets, BID X 14 days | Drug | 1 |
| pafuramidine maleatePafuramidine maleate, 100 mg tablet BID X 14 days | Drug | 2 |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: FDA Full Clinical Hold due to safety concerns, as of 12/21/07). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anina M Van der Bijil, MD principal investigator
Farmovs-Parexel Clinical Research Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pafuramidine maleate in people with Healthy, run by Immtech Pharmaceuticals, Inc at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: FDA Full Clinical Hold due to safety concerns, as of 12/21/07). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.