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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54DA039002-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Pennsylvania | OTHER |
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The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.
This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg. Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12 completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions.
The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO) | Experimental | Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo |
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| CLAV 250mg; PBO; then CLAV 500mg | Experimental | Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg |
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| PBO; CLAV 250mg; then CLAV 500mg | Experimental | Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clavulanic acid | Drug | Clavulanic acid will be administered orally in 250mg capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Adverse Events (AEs) | Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs. | 6 Days (Study Days 1, 2, 3, 4, 5, 10) |
| Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported. | 4 Days (Study Days 2, 3, 4, 5) |
| Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported. | 4 Days (Study Days 2, 3, 4, 5) |
| Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing | ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter of Cocaine-concentration | Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg). | 3 Days (Study Days 2, 3, 4) |
| Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses |
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Inclusion Criteria:
Exclusion Criteria:
(For full inclusion/exclusion criteria or for more information, please contact the site directly.)
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| Name | Affiliation | Role |
|---|---|---|
| Kyle M. Kampman, M.D. | U54 Principal Investigator - University of Pennsylvania | Principal Investigator |
| Mary F. Morrison, M.D., M.S. | Temple University | Principal Investigator |
| M. I Walters, M.D. | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital - Episcopal Campus | Philadelphia | Pennsylvania | 19125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19128205 | Background | Uys JD, LaLumiere RT. Glutamate: the new frontier in pharmacotherapy for cocaine addiction. CNS Neurol Disord Drug Targets. 2008 Nov;7(5):482-91. doi: 10.2174/187152708786927868. | |
| 20383795 | Background | Rasmussen BA, Baron DA, Kim JK, Unterwald EM, Rawls SM. beta-Lactam antibiotic produces a sustained reduction in extracellular glutamate in the nucleus accumbens of rats. Amino Acids. 2011 Feb;40(2):761-4. doi: 10.1007/s00726-010-0589-0. Epub 2010 Apr 13. |
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10 subjects were randomized to one of three treatment arms in a double masked method.
This was an inpatient study at Temple University, Episcopal Hospital in Philadelphia, Pennsylvania with subjects recruited between 10/24/2016 and 6/04/2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo; Clav 250mg, Then Clav 500mg | Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #1 IV cocaine only; Day #2: Placebo mg; Day #3: Clav 250 mg; Day #4: Clav 500mg |
| FG001 | Clav 250mg; Placebo; Then Clav 500mg | Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #2: Clav 250 mg; Day #3: Placebo; Day #4: Clav 500 mg |
| FG002 | Clav 250mg; Clav 500mg; Then Placebo | Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day 1# IV cocaine only; Day #2: Clav 250 mg; Day #3: Clav 500 mg; Day #4: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IV Cocaine Only (Day 1) |
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| FIrst Treatment (Day 2) |
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| Second Treatment (Day 3) |
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| Third Treatment (Day 4) |
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| Added 750mg Dose of CLAV (Day 5) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clavulanic Acid (CLAV) 250mg, CLAV 500mg Then Placebo (PBO) | Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo Clavulanic acid Intravenous cocaine Placebo |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Severe Adverse Events (AEs) | Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs. | Participants were adults (18-65) with current cocaine use disorder who were recruited from the greater Philadelphia area. | Posted | Count of Participants | Participants | 6 Days (Study Days 1, 2, 3, 4, 5, 10) |
|
Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Day 1-IV Cocaine Infusion Only | Subjects received IV cocaine 20mg and then at least 2hr 45min later they received IV cocaine 40mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection (URI) | Infections and infestations | MedDRA | Systematic Assessment | one with upper respiratory infection; one with flu |
The sample size was relatively small (n=10) and the current study was not powered to adequately explore efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yaminah Carter Research Coordinator | Temple University Episcopal Hospital | 2678097602 | yaminah.carter@tuhs.temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Aug 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Intravenous cocaine | Drug | 20/40mg Cocaine will be administered by IV |
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| Placebo | Drug | Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose |
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| 4 Days (Study Days 2, 3, 4, 5) |
CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4. The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0. |
| 3 Days (Study Days 2, 3, 4) |
| Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses | The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion | 3 days (Day 2, 3, 4) |
| Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid | Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted. | 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4 |
| 21543969 | Background | Ward SJ, Rasmussen BA, Corley G, Henry C, Kim JK, Walker EA, Rawls SM. Beta-lactam antibiotic decreases acquisition of and motivation to respond for cocaine, but not sweet food, in C57Bl/6 mice. Behav Pharmacol. 2011 Aug;22(4):370-3. doi: 10.1097/FBP.0b013e3283473c10. |
| 23031254 | Background | Kovalevich J, Corley G, Yen W, Rawls SM, Langford D. Cocaine-induced loss of white matter proteins in the adult mouse nucleus accumbens is attenuated by administration of a beta-lactam antibiotic during cocaine withdrawal. Am J Pathol. 2012 Dec;181(6):1921-7. doi: 10.1016/j.ajpath.2012.08.013. Epub 2012 Sep 29. |
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| CLAV 250mg, PBO, Then CLAV 500mg |
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg Clavulanic acid Intravenous cocaine Placebo |
| BG002 | PBO, CLAV 250mg Then CLAV 500mg | Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg Clavulanic acid Intravenous cocaine Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education Level | Phenotypes and eXposures (PhenX) demographic toolkit. Only number of participants who completed High School/General Educational Development Equivalent or greater are reported | Count of Participants | Participants |
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| Placebo (PBO) |
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol |
| OG002 | CLAV 250mg | CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol |
| OG003 | CLAV 500mg | CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol |
| OG004 | Day 5--CLAV 750mg | CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol. |
| OG005 | Day 10--Follow up | 5-6 days after discharge, subjects returned for a follow up visit to assess adverse events |
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| Primary | Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported. | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | Posted | Mean | Standard Deviation | beats per minute | 4 Days (Study Days 2, 3, 4, 5) |
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| Primary | Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported. | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | Posted | Mean | Standard Deviation | mm Hg | 4 Days (Study Days 2, 3, 4, 5) |
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| Primary | Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing | ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported. | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | Posted | Mean | Standard Deviation | ms | 4 Days (Study Days 2, 3, 4, 5) |
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| Secondary | Pharmacokinetic (PK) Parameter of Cocaine-concentration | Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg). | All 10 participants received PBO, CLAV 250mg or 500mg over 3 days in different order according to randomization. One participant is not included in the analysis due to inadequate samples obtained. | Posted | Mean | Standard Deviation | mg/L | 3 Days (Study Days 2, 3, 4) |
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| Secondary | Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses | CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4. The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0. | 10 subjects received 250mg and 500mg (randomized to different days) but samples for one subject was unusable. A second subject vomited 5 min after both the 250mg dose and the 500mg dose and levels were undetectable; this subject was excluded from analysis. This reports results of 8 subjects. | Posted | Median | Full Range | mg/L | 3 Days (Study Days 2, 3, 4) |
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| Secondary | Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses | The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion | 10 subjects were randomized and received 250mg and 500mg on different days based on their randomization. One subject's samples were unusable. A second subject vomited after each dose (250mg and 500mg), had nondetectable levels and was excluded in the calculation. This analysis is based on 8 subjects. | Posted | Median | Full Range | mg/L | 3 days (Day 2, 3, 4) |
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| Secondary | Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid | Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted. | 10 subjects receiving IV cocaine infusion were randomized to receive either PBO, CLAV 250mg or CLAV 500mg on days 2, 3,and 4 depending on randomization | Posted | Median | Inter-Quartile Range | mm | 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Placebo + IV Cocaine | Subjects were randomized to receive oral matched placebo (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | CLAV 250mg + IV Cocaine | Subjects were randomized to receive oral CLAV 250mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later | 0 | 10 | 0 | 10 | 3 | 10 |
| EG003 | CLAV 500mg + IV Cocaine | Subjects were randomized to receive oral CLAV 500mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later | 0 | 10 | 0 | 10 | 3 | 10 |
| EG004 | Day 5--CLAV 750mg + IV Cocaine | Protocol V2.3 allowed for subjects to proceed to day 5 receiving 750mg after they completed Day 2,3 and 4 and received PBO, CLAV 250mg and CLAV 500mg iper day n some randomized order | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | Discharge Day | Day after last dose of study drug (Day 6 for those completing day 5 CLAV 750mg; ot Day 5 for those completing days 1-4 only) | 0 | 10 | 0 | 10 | 5 | 10 |
| EG006 | Day 10-Follow-up | All subjects returned for a follow-up visit on Day 10 of the study (5-6 days after discharge) | 0 | 10 | 0 | 10 | 4 | 10 |
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| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment | Two occurrences in one subject: 3 consecutive ventricular complexes on day 1 and 4 consecutive beats ventricular complexes on day of CLAV 500mg dose |
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| Abdominal gas | Gastrointestinal disorders | MedDRA | Systematic Assessment | 3 events in 2 subjects; one subject had event on day 1 and CLAV 250mg day. The 2nd subject's event was on discharge day |
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| Nausea+vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment | 2 events in 1 subject--after CLAV 250mg and CLAV 500mg |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Indigestion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Reaction to Telemetry Pads on Skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Itchy Skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Itchiness was located near IV injection site |
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| Teary eyes | Eye disorders | MedDRA | Systematic Assessment |
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| Lower eyelid twitch rhythmic | Eye disorders | MedDRA | Systematic Assessment | Right eye only |
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| Elevated calcium levels | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hand bilateral spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Lightheaded | Nervous system disorders | MedDRA | Systematic Assessment | 1 subject, 4 events |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment | 3 subject, 4 events; one subject had headache on day 5 (CLAV 750mg) and day 6 (discharge day) |
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| Drowsiness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Tooth Ache | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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The results in this trial are considered proprietary and still under evaluation.
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Max change in HR from baseline |
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| Max change in SBP |
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| DBP at 2 mim |
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| Max change in DBP |
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| Superiority |
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| 15 min post-infusion |
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| 30 min post-infusion |
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| 45 min post-infusion |
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