- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314713
A Study to Evaluate the Intramuscular Administration of Scopolamine
May 31, 2022 updated by: Battelle Memorial Institute
A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluated The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection
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
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This is a double-blinded, randomized, placebo-controlled, in-clinic, Phase 1, single-dose, IM, sequential dose-escalation study in healthy adults aged 18-55.
Healthy volunteers will be assigned to 1 of 5 cohorts of Scopolamine HBT dosage groups: 0.005, 0.007, 0.011, 0.014, or 0.021 mg/kg, or will receive the placebo administered by IM injection to the anterior thigh.
In each cohort, 6 to 9 subjects will receive active drug and 2 to 3 subjects will receive placebo.
Each cohort will have at least 3 male and 3 female subjects enrolled among the first 8 subjects in the dosing group to ensure that at least 1 male subject and 1 female subject in each dosing group receive active drug.
If nonextreme dose-limiting toxicities are observed in any of the cohorts, 4 additional subjects, 3 active and 1 placebo, may be added to each cohort.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Pharmaron
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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)
- A male with a female partner of childbearing potential must agree to use a barrier method of contraception (defined as condoms with spermicide) for at least 30 days following drug administration
- If male, must not have past diagnoses of benign prostatic hypertrophy or urinary tract obstruction and must not have on screening history/review of systems symptoms suggestive of urinary tract obstruction (eg, urinary hesitancy, urgency, frequency, or nocturia)
- Nonsmoker/tobacco/nicotine product (including e-cigarettes) user within 3 months of first dosing and must have a total lifetime exposure to cigarettes of < 15 pack-years
- No evidence of significant neuropsychiatric disorders based on the Brief Psychiatric Rating Scale (BPRS) at screening and prior to drug administration, which is defined as having a global score of ≤ 25 with no score higher than 2 on any one item, with the exception of a score of 1 (ie, Not Present) to disorientation, hallucinatory behavior, and suspiciousness (ie, paranoia)
- No evidence of suicidal ideation or behavior at screening and prior to drug administration, which is defined as having a global score of 0 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Ability to read, speak, and comprehend English and a willingness to sign informed consent
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
- Has any specified laboratory values (eg, hematology, serum chemistry, and urinalysis) outside of the normal range for age and sex and deemed clinically significant by the investigator within 30 days before drug administration
- Has positive (reactive) test results for hepatitis B surface antigen, hepatitis C, syphilis, HIV-1, or HIV-2
- Has narrow-angle glaucoma or high intraocular pressures in either or both eyes
- Has pyloric obstruction or urinary bladder neck obstruction
- Has impaired liver or kidney functions
- Clinically relevant electrocardiogram (ECG) abnormalities on any 12-lead ECG obtained at screening or prior to dosing
- ECG with a PR interval ≥ 200 msec at screening or prior to dosing
- ECG with QRS duration > 120 msec at screening or prior to dosing
- ECG RR interval > 1500 msec at screening or prior to dosing
- ECG with a QTc interval > 450 msec for males or 470 msec for females (QT interval corrected with Fridericia correction [QTcF]) at screening or prior to dosing
- Systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg at screening or prior to dosing
- Systolic blood pressure < 90 mm Hg and/or diastolic blood pressure < 50 mm Hg at screening or prior to dosing
- Currently taking or has taken other antimuscarinic drugs such as phenothiazines, tricyclic antidepressants, antihistamines (including meclizine), meperidine, or other anticholinergics that have weak antimuscarinic activity or that cause drowsiness, including antidepressants, benzodiazepines, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants within 72 hours prior to dosing
- Has taken, within 14 days of planned dosing, any prescription or nonprescription medication (including home remedies, herbal supplements, or nutritional supplements) unless the PI/subinvestigator, in consultation with the medical monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescriptions drugs will be grounds for exclusion)
- History of major DSM-5 Axis I or II disorder, or evidence of such disorder at Day -1 as determined via the Structured Clinical Interview for DSM-5, customized Clinical Trials version (SCID-5-CT)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Scopolamine HBT 0.005 mg/kg
Dose of Scopolamine 0.005mg/kg verses Placebo
|
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo Comparator: Scopolamine HBT 0.007 mg/kg
Dose of Scopolamine 0.007mg/kg verses Placebo
|
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo Comparator: Scopolamine HBT 0.011 mg/kg
Dose of Scopolamine 0.011mg/kg verses Placebo
|
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo Comparator: Scopolamine HBT 0.014 mg/kg
Dose of Scopolamine 0.014mg/kg verses Placebo
|
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
Placebo Comparator: Scopolamine HBT 0.021 mg/kg
Dose of Scopolamine 0.021mg/kg verses Placebo
|
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
|
No Intervention: Placebo
Placebo controlled
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine degree and number of adverse events experienced by subjects.
Time Frame: 30 Days (+7)
|
To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
|
30 Days (+7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine what the what the body does with the movement of drug within the body of Scopolamine HBT after IM Administration.
Time Frame: 30 Days (+7)
|
A goal of this clinical study is to measure Scopolamine HBT immunity remaining in each participant after IM administration.
The predicted efficacious Cmax, based on limited nonclinical studies, is 16-18 ng/mL.
At the end of each cohort, the PI, DSMB, and sponsor will evaluate the safety outcomes and PK data associated with the Scopolamine HBT dosing for that group.
|
30 Days (+7)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2020
Primary Completion (Actual)
April 6, 2021
Study Completion (Actual)
May 6, 2021
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 17, 2020
First Posted (Actual)
March 19, 2020
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- S-16-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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