Traumatic Brain InjuryPhase 1NCT01132703
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
A Phase 1 study testing Glyburide for Injection in people with Traumatic Brain Injury and Stroke, run by Biogen at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Stroke
- What is being tested?
- Glyburide for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2010to 7 May 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male or a healthy nonpregnant, nonlactating female.
- Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
- Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
- A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
- A negative urine or saliva test for selected substances of abuse and cotinine.
Who cannot join
- Clinically significant history of hypoglycemia as assessed by the investigator.
- History of seizure disorder, even if currently not receiving anticonvulsant medications.
- History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
- Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day 1.
- A history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable).
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- Use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. Exceptions may be made by the medical monitor on a case-by-case basis.
- Received another investigational drug within 30 days prior to randomization.
- A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at screening. If the HIV test is positive, the subject will be informed privately and referred for additional counseling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of RP-1127 (Glyburide for Injection) in Healthy Male and Female Volunteers
The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
Read the detailed description
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
- Conditions
- Traumatic Brain Injury, Stroke
- Being tested
- Glyburide for Injection, Placebo
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyburide for InjectionDrug
Also called RP-1127, glibenclamide, glybenclamide
Administered as specified in the Treatment Arm.
PlaceboDrug
Administered as specified in the Treatment Arm.
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours. Receives: Drug: Placebo |
| Glyburide for Injection: Dose 1 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours Receives: Drug: Glyburide for Injection |
| Glyburide for Injection: Dose 2 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours Receives: Drug: Glyburide for Injection |
| Glyburide for Injection: Dose 3 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours. Receives: Drug: Glyburide for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events and Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurence such as a sign, symptom, and/or laboratory finding that is concurrent with the use of a drug in humans. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event
Measured: Up to Day 28
Secondary outcomes (8)
Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Volume of Distribution (Vz)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Elimination Rate Constant (λz)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Half-Life (t1/2)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax)
Measured: Day 1 (baseline) and at multiple time points up to Day 5
Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose
Measured: Day 1 (baseline) and at multiple time points up to Day 5
PD Parameter of Glyburide: Change from Baseline in Serum Insulin
Measured: Day 1 (baseline) and at multiple time points up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study start7 Jan 2010
- Primary completion7 May 2010
- Study completion7 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132703
- Sponsor's protocol ID
- RPI 101
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2010
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of RP-1127 (Glyburide for Injection) in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01132703
- Acronym / sponsor ID
- RPI 101
- Conditions
- Traumatic Brain Injury, Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2010 (actual)
- Primary completion
- 7 May 2010 (actual)
- Study completion
- 7 May 2010 (actual)
- First posted
- 28 May 2010 (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 primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
Detailed description
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: PlaceboMatching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours. |
| Glyburide for Injection: Dose 1 | Experimental | Drug: Glyburide for InjectionGlyburide is administered as a bolus followed by a infusion for 72 hours |
| Glyburide for Injection: Dose 2 | Experimental | Drug: Glyburide for InjectionGlyburide is administered as a bolus followed by a infusion for 72 hours |
| Glyburide for Injection: Dose 3 | Experimental | Drug: Glyburide for InjectionGlyburide is administered as a bolus followed by a infusion for 72 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy male or a healthy nonpregnant, nonlactating female.
- Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
- Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
- A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
- A negative urine or saliva test for selected substances of abuse and cotinine.
Key exclusion criteria (9 listed)
- Clinically significant history of hypoglycemia as assessed by the investigator.
- History of seizure disorder, even if currently not receiving anticonvulsant medications.
- History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
- Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day 1.
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 |
|---|---|---|
| Glyburide for InjectionAlso: RP-1127, glibenclamide, glybenclamideAdministered as specified in the Treatment Arm. | Drug | Glyburide for Injection: Dose 1, Glyburide for Injection: Dose 2, Glyburide for Injection: Dose 3 |
| PlaceboAdministered as specified in the Treatment Arm. | Drug | Matching Placebo |
Primary outcome
Number of Participants with Adverse Events and Serious Adverse Events
Time frame: Up to Day 28
An adverse event (AE) is defined as any untoward medical occurence such as a sign, symptom, and/or laboratory finding that is concurrent with the use of a drug in humans. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event
8 secondary outcomes
Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Volume of Distribution (Vz)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Elimination Rate Constant (λz)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Half-Life (t1/2)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PD Parameter of Glyburide: Change from Baseline in Serum Insulin
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
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 21 Jun 2021.
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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.
Medical Director study director
Biogen
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 Glyburide for Injection in people with Traumatic Brain Injury and Stroke, run by Biogen 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 5 inclusion and 9 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 21 Jun 2021. 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. 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?
Number of Participants with Adverse Events and Serious Adverse Events (time frame: Up to Day 28). 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 21 Jun 2021.