Hysterectomy, Surgery
Conditions
Brief summary
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
Detailed description
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Interventions
DRUGIS-001
10mg, 20mg or 40 mg IV IS-001 drug administered during surgery
DEVICEda Vinci® Si/Xi Surgical System
robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is between the ages of 18 and 65. 2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging. 3. Subject is willing and able to provide informed consent. 4. Subject is considered capable of complying with study procedures. 5. Subject has no medical history of liver or kidney disease. 6. Subject has no evidence of NYHA Class II-IV cardiac disease. 7. Subject has recent (\< 3 months) clinical hematology (CBC) values within the acceptable values reference range. 8. Subject has recent (\< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.
Exclusion criteria
1. Subject is pregnant or nursing. 2. Subject has a history of alcoholism. 3. Subject has a history of drug abuse. 4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 5. Subject has known human immunodeficiency virus (HIV) infection. 6. Subject has been diagnosed with or treated for cancer in the last 2 years. 7. Subject has a total body weight \< 32 kg. 8. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg. 9. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm. 10. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events) | 14 days | Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pharmacokinetic parameter of IS-001: Cmax | 6 hours | Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration |
| Evaluation of pharmacokinetic parameter of IS-001: Tmax | 6 hours | Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration |
| Evaluation of pharmacokinetic parameter of IS-001: t1/2 | 6 hours | Pharmacokinetics for IS-001 as measured by terminal elimination half-life |
| Evaluation of pharmacokinetic parameter of IS-001: AUC | 6 hours | Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve |
Countries
United States
Outcome results
None listed