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 range18 Years – 55 Years
SexALL
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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
✓. 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
✕
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.
Timeframe: 30 Days (+7)
8
AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
. 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
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.