A Study to Evaluate the Intramuscular Administration of Scopolamine (NCT04314713) | Clinical Trial Compass
TerminatedPhase 1
A Study to Evaluate the Intramuscular Administration of Scopolamine
Stopped: DSMB decision due to adverse events
United States32 participantsStarted 2020-06-02
Plain-language summary
To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection. And characterize the pharmacokinetics (PK) of ascending doses of Scopolamine HBT administered by IM injection
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18 to 55 years of age, inclusive, at the time of drug administration
. Without clinically significant abnormities on physical examination at screening or prior to drug administration
. Generally healthy, as determined by medical history review, physical examination, and laboratory testing at screening and prior to drug administration
. Must have a BMI (body mass index) of ≥ 19.0 and ≤ 30.0, and weight range of 55.0 to 85.0 kg at screening or prior to drug administration
. Must have adequate venous access and sufficient upper leg muscle tissue for drug administration
. If female, the subject must be nonpregnant and nonbreastfeeding, and have a negative serum pregnancy test at screening and prior to drug administration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine Degree and Number of Adverse Events Experienced by Subjects.
Timeframe: 30 Days (+7)
2
Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
3
Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
4
Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
5
t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
6
Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
7
MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
. If female of childbearing potential, the subject must have been using adequate contraception (as defined in Section 5.3.1.5) for at least 3 months prior to drug administration and must agree to use an adequate method of contraception for at least 30 days following drug administration
. Females of nonchildbearing potential are also eligible, defined as a subject who is postmenopausal (continuous amenorrhea for 24 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy)
Exclusion criteria
. Received any other investigational drug within 30 days prior to drug administration
. Known allergies to any component of the study drug, other belladonna alkaloids, or the recovery medications (physostigmine, atropine, or benzodiazepines \[diazepam or lorazepam\])
. History of migraine headaches or seizures
. History of psychosis or psychotic episodes
. Clinically relevant abnormal physical findings (including vital signs) as determined by the investigator at screening or prior to drug administration that could interfere with the objectives of the study or the safety of the subject
. Has ongoing drug abuse/dependence (including alcohol), recent history (over the past 5 years) of treatment for alcohol or drug abuse, or a current positive alcohol breathalyzer test or current positive urine test for drugs of abuse (as defined in Section 11.1.9.5) at screening or prior to drug administration
. Has consumed Seville orange (bitter orange), grapefruit, grapefruit juice, other grapefruit-containing products, or starfruit within 7 days prior to dosing
. Has consumed caffeine or other xanthine-containing products within 7 days prior to dosing
8
AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
9
AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
10
Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Timeframe: 30 Days (+7)
11
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.