NCT04093050CompletedPhase 1
A Phase 1, Open-Label, Two-Arm, Parallel-Group, Pharmacokinetic Study on Plasma Clearance of Vasopressin in Healthy Volunteers
Endo Pharmaceuticals2 sites in 1 country41 target enrollmentStarted: October 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype
Study Overview
Brief Summary
Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed the informed consent form (ICF) approved by an institutional review board (IRB).
- •Determined to have genotype TT, AA, or AT.
- •Weighs at least 50 kg and not more than 100 kg.
- •If female, must be surgically sterile for at least 6 months prior to screening, post-menopausal for at least 1 year, using adequate contraception, have a vasectomized partner or abstinent.
- •Participant is in good physical health as determined by the investigator, based on physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory tests.
- •Participant is willing and able to comply with all aspects of the protocol, including the diet and medication restrictions.
Exclusion Criteria
- •If female, breastfeeding or pregnant.
- •Use of any prescription or over-the-counter drugs.
- •Clinical laboratory test results outside laboratory normal range that are determined by the investigator to be clinically significant.
- •Creatinine clearance <90 mL/min (estimated by Cockcroft-Gault formula).
- •Pulse rate ≤50 or ≥100 bpm, systolic blood pressure ≤90 or ≥140 mmHg, diastolic blood pressure ≤60 or ≥90 mmHg or a history of hypertension, recurrent hypotensive events, or known orthostatic hypotension.
- •ECG abnormalities (PR >200 msec; QRS complex >120 msec; QT interval corrected for heart rate using Fridericia's formula [QTcF] interval >450 msec if male and >470 msec if female, or history of clinically significant ECG abnormalities (such as cardiac arrhythmia, familial long QT syndrome, or previous torsade de pointes).
- •History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
- •History or evidence of any clinically significant surgical or medical condition (eg, cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, dermatologic, renal, and/or another major disease or malignancy) that would be anticipated, in the opinion of the investigator, to compromise participant safety or PK evaluation.
- •Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
- •Clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies), as judged by the investigator.
- •History of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
- •Use of tobacco- or nicotine-containing products in the 6 months prior or intent to smoke during the study. Smoking status will be confirmed by negative urine cotinine test.
- •Consumption of more than 21 units (males) or more than 14 units (females) of alcohol per week (1 unit = 10 g pure alcohol or 250 mL of beer [5%], 35 mL of spirits [35%], or 100 mL of wine [12%]). Alcohol use is prohibited from 72 hours prior to admission on Day -2 until discharge from clinical unit.
- •History of chronic drug or alcohol abuse in the last 4 years. Lack of abuse will be confirmed by urine screens for alcohol and drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, methamphetamines, methylenedioxymethamphetamine, and opiates [including heroin, codeine, and oxycodone]).
- •Participation in a clinical trial of an investigational drug within the 30 days prior to admission on Day -
- •Significant blood loss or donation (≥500 mL within the 30 days prior to admission on Day -2).
- •Is an employee or the close relative of an employee of the sponsor or clinical unit.
Arms & Interventions
TT Genotype
Experimental
Intervention: Vasostrict Injectable Product (Drug)
AA/AT Genotype
Experimental
Intervention: Vasostrict Injectable Product (Drug)
Outcomes
Primary Outcomes
Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype
Time Frame: 15 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
Topotecan Pharmacokinetic Characterization StudyCancerNCT00361803GlaxoSmithKline15
Completed
Phase 1
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic FibrosisCystic FibrosisNCT05225805Nabriva Therapeutics AG13
Completed
Phase 1
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic FunctionHepatic ImpairmentNCT03799848Akebia Therapeutics24
Completed
Phase 1
Single and Multiple Dose Study of VER-01 in Healthy VolunteersHealthyNCT04930809Vertanical GmbH42
Completed
Phase 1
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing PotentialBreast CancerNCT02621957Genentech, Inc.15