Heart FailurePhase 1NCT01944683
A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
A Phase 1 study testing GGF2 and Midazolam in people with Heart Failure, run by Acorda Therapeutics at 8 sites in United States.
Trial summary
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- GGF2 and Midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2013to Jul 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
- If male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. Must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
- Stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
- All cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to Day 1
Who cannot join
- Any previous exposure to GGF2 or other neuregulins
- Initiation or change of a prescription medication within the 2 weeks prior to Day 1, and/or concomitant medication regimen is expected to change during the course of the study
- Known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of GGF2 diluent
- Known specific hepatic disease; total bilirubin >2 mg/dL, AST > 100 IU
- History of hepatic impairment (hepatitis B and C)
- Type I Diabetes
- Documented stroke or transient ischemic attack (TIA) within 2 months of study enrollment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Duke Clinical Research Unit
Durham, North Carolina, 27710
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
UCSD Medical Center
La Jolla, California, 92037
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Orange County Research Center
Tustin, California, 92780
About this study
Official title: Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
Read the detailed description
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.
- Conditions
- Heart Failure
- Being tested
- Placebo, GGF2, Midazolam
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
GGF2Drug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| GGF2 | Experimental | Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively. Receives: Drug: GGF2; Drug: Midazolam |
| Placebo | Placebo comparator | Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively. Receives: Other: Placebo; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)
Measured: 90 days (± 3 days)
Pharmacokinetic (PK) parameter Area Under the Curve (AUC) of a single dose of midazolam when administered prior to and following a single IV infusion of GGF2 or Placebo
Measured: Day 1 to Day 7
Secondary outcomes (4)
Change from baseline of 2D-Echocardiogram (2D-ECHO) or ECHO with contrast
Measured: Visit 1 (day-14 to day-1) and visits 2-5 (day 8 through day 90 ± 3 days)
Change from baseline of the Six-Minute Walk Test (6MWT)
Measured: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of metabolic testing measuring maximum capacity of body to transport and use oxygen during incremental exercise (VCO2 and VO2 max)
Measured: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of the M.D. Anderson Symptom Inventory (MDASI) score
MDASI is a questionnaire asking patients about the severity of their heart disease symptoms and impact of the symptoms on daily functioning during the past 24 hours.
Scale ranges from 0 (sympton has not been present) to 10 (the symptom was as bad as you can imagine it could be).
Measured: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Eisen, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944683
- Sponsor's protocol ID
- GGF2-CV-1007
- Status last verified
- Jul 2016
- First submitted
- 11 Sep 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01944683
- Acronym / sponsor ID
- GGF2-CV-1007
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Sep 2013 (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.
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
Detailed description
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GGF2 | Experimental | Drug: GGF2, Drug: MidazolamPatients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion. Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively. |
| Placebo | Placebo comparator | Other: Placebo, Drug: MidazolamPatients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion. Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- If female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
- If male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. Must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
- Stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
- All cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to Day 1
Key exclusion criteria (7 listed)
- Any previous exposure to GGF2 or other neuregulins
- Initiation or change of a prescription medication within the 2 weeks prior to Day 1, and/or concomitant medication regimen is expected to change during the course of the study
- Known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of GGF2 diluent
- Known specific hepatic disease; total bilirubin >2 mg/dL, AST > 100 IU
- History of hepatic impairment (hepatitis B and C)
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 |
|---|---|---|
| Placebo | Other | Placebo |
| GGF2 | Drug | GGF2 |
| Midazolam | Drug | GGF2, Placebo |
Primary outcome
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)
Time frame: 90 days (± 3 days)
Pharmacokinetic (PK) parameter Area Under the Curve (AUC) of a single dose of midazolam when administered prior to and following a single IV infusion of GGF2 or Placebo
Time frame: Day 1 to Day 7
4 secondary outcomes
Change from baseline of 2D-Echocardiogram (2D-ECHO) or ECHO with contrast
Time frame: Visit 1 (day-14 to day-1) and visits 2-5 (day 8 through day 90 ± 3 days)
Change from baseline of the Six-Minute Walk Test (6MWT)
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of metabolic testing measuring maximum capacity of body to transport and use oxygen during incremental exercise (VCO2 and VO2 max)
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of the M.D. Anderson Symptom Inventory (MDASI) score
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
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 13 Jul 2016.
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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.
Andrew Eisen, MD study director
Acorda Therapeutics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GGF2 and Midazolam in people with Heart Failure, run by Acorda Therapeutics at 8 sites 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 4 inclusion and 7 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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 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?
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE) (time frame: 90 days (± 3 days)). The study lists 2 primary outcomes in all. 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 13 Jul 2016.