HealthyPhase 1NCT01587313
A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers
A Phase 1 study testing Isosorbide dinitrate / hydralazine capsules in people with Healthy, run by Arbor Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isosorbide dinitrate / hydralazine capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2012
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, nonsmoking, slow acetylator (as determined by caffeine metabolite assay) males or females between the ages of 18 to 40 years inclusive.
- Body weight at least 150 pounds and Body Mass Index between 18.5 and 30 kg/m2.
- Medical history, physical examination, and clinical laboratory test results indicating either normal vital organ/endocrine functions, or no clinically significant abnormalities.
- Clinical laboratory testing negative for: HIV, Hepatitis B surface antigen and Hepatitis C antibody.
- Urine testing negative for drugs of abuse (including, but not limited to marijuana, amphetamines, barbiturates and cocaine).
- Negative urine cotinine test and negative saliva alcohol test.
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- Negative urine HCG test, consistent with no pregnancy (females only).
- For female subjects, a recent history of menses that is regular for the individual (24 36 day cycles).
- Females participating in this study must be:
- unable to have children (e.g., post-menopausal, tubal ligation, hysterectomy) OR
- willing to remain abstinent [not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 14 days after the last dose] OR
- willing to use two effective barrier methods of birth control (partner using condom and female using IUD, diaphragm plus spermicide, or contraceptive sponge).
- Ability to grant voluntary informed consent to participate in the study.
Who cannot join
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- Use of prescription or OTC drug(s), other than acetaminophen, within two weeks of first dose of study drug and throughout study unless approved by the investigator or sponsor.
- Use of alcohol or caffeine containing products within 48 hours of each dose of study drug.
- History of, or evidence of clinically significant medical condition, including, but not limited to hepatic, renal, cardiac, vascular, gastrointestinal, or thyroid disease, diabetes, epilepsy, respiratory or hematological disease, acute narrow angle glaucoma or psychiatric disorder which, in the opinion of the Investigator would confound the study results or present a risk to the subject.
- History of alcohol or drug abuse within one year of study participation.
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- Presence of, or known hypersensitivity, allergy, idiosyncratic reaction or adverse reaction to caffeine, ISDN, hydralazine HCl, or any compounds with similar chemical characteristics.
- Received an investigational drug within 30 days of the first dose in this study.
- Blood pressure less than 110/70 mm Hg at screening or at Day 1 prior to dosing.
- Donated one pint or more of blood or donated platelets within 30 days of the first dose in this study.
- Any subject who, in the opinion of the Investigator, cannot follow instructions.
- With regard to females; pregnancy, lactation, or the use of hormonal contraception.
- History of lupus erythematous or lupus like syndrome.
- Use of herbal preparations or use of phosphodiesterase inhibitors.
- Employee of the Sponsor or CRO.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Cinical Services
Hackensack, New Jersey, 07601
About this study
Official title: A Four-arm, Single Dose, Two-Period, Pharmacokinetic Study of BiDil SR and IR Capsules and Commercial BiDil Tablets
This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time.
- Conditions
- Healthy
- Being tested
- Isosorbide dinitrate / hydralazine capsules
- Keywords
- hydralazine, isosorbide, bidil, volunteers, pharmacokinetic profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide dinitrate / hydralazine capsulesDrug
Also called BiDil tablets; ISDN/HYD
Group 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 am Receives: Drug: Isosorbide dinitrate / hydralazine capsules |
| Group 2 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 5 pm Receives: Drug: Isosorbide dinitrate / hydralazine capsules |
| Group 3 | Experimental | ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 pm Receives: Drug: Isosorbide dinitrate / hydralazine capsules |
| Group 4 | Active comparator | ISDN/HYD 1 IR cap and two SR caps at 8 am crossover to Day 8: BiDil Tablet tid Receives: Drug: Isosorbide dinitrate / hydralazine capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma/blood concentration versus time curve, as calculated by the linear trapezoidal method for Hydralazine and ISDN and metabolites.
Measured: from time zero (0) to 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory J Tracey, MD, Principal investigator, Frontage Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587313
- Sponsor's protocol ID
- AR06.004
- Status last verified
- Aug 2015
- First submitted
- 26 Apr 2012
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-arm, Single Dose, Two-Period, Pharmacokinetic Study of BiDil SR and IR Capsules and Commercial BiDil Tablets
- ClinicalTrials.gov ID
- NCT01587313
- Acronym / sponsor ID
- AR06.004
- Conditions
- Healthy
- Keywords
- hydralazine, isosorbide, bidil, volunteers, pharmacokinetic profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Apr 2012 (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 single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Isosorbide dinitrate / hydralazine capsulesISDN/HYD 2 SR caps crossover to 1 IR cap at 8 am |
| Group 2 | Experimental | Drug: Isosorbide dinitrate / hydralazine capsulesISDN/HYD 2 SR caps crossover to 1 IR cap at 5 pm |
| Group 3 | Experimental | Drug: Isosorbide dinitrate / hydralazine capsulesISDN/HYD 2 SR caps crossover to 1 IR cap at 8 pm |
| Group 4 | Active comparator | Drug: Isosorbide dinitrate / hydralazine capsulesISDN/HYD 1 IR cap and two SR caps at 8 am crossover to Day 8: BiDil Tablet tid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy, nonsmoking, slow acetylator (as determined by caffeine metabolite assay) males or females between the ages of 18 to 40 years inclusive.
- Body weight at least 150 pounds and Body Mass Index between 18.5 and 30 kg/m2.
- Medical history, physical examination, and clinical laboratory test results indicating either normal vital organ/endocrine functions, or no clinically significant abnormalities.
- Clinical laboratory testing negative for: HIV, Hepatitis B surface antigen and Hepatitis C antibody.
- Urine testing negative for drugs of abuse (including, but not limited to marijuana, amphetamines, barbiturates and cocaine).
Key exclusion criteria (15 listed)
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- Use of prescription or OTC drug(s), other than acetaminophen, within two weeks of first dose of study drug and throughout study unless approved by the investigator or sponsor.
- Use of alcohol or caffeine containing products within 48 hours of each dose of study drug.
- History of, or evidence of clinically significant medical condition, including, but not limited to hepatic, renal, cardiac, vascular, gastrointestinal, or thyroid disease, diabetes, epilepsy, respiratory or hematological disease, acute narrow angle glaucoma or psychiatric disorder which, in the opinion of the Investigator would confound the study results or present a risk to the subject.
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 |
|---|---|---|
| Isosorbide dinitrate / hydralazine capsulesAlso: BiDil tablets; ISDN/HYDGroup 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Area under the plasma/blood concentration versus time curve, as calculated by the linear trapezoidal method for Hydralazine and ISDN and metabolites.
Time frame: from time zero (0) to 24 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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.
Gregory J Tracey, MD principal investigator
Frontage Laboratories, Inc.
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 Isosorbide dinitrate / hydralazine capsules in people with Healthy, run by Arbor Pharmaceuticals, Inc. at 1 site in United States.
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 13 inclusion and 15 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: finished, as of the sponsor's last update on 6 Aug 2015. 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 United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma/blood concentration versus time curve, as calculated by the linear trapezoidal method for Hydralazine and ISDN and metabolites. (time frame: from time zero (0) to 24 hr). 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 6 Aug 2015.