First in Humans Study of JDTic

NCT01431586 | Terminated Phase 1 DMC

• 2 other identifiers: JDTic-001U19DA021002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first study to be conducted in humans for JDTic, a new chemical entity, with evaluations focusing on the safety, tolerability, and pharmacokinetics (PK) of JDTic following administration of single oral doses. JDTic is a novel, selective κ opioid receptor antagonist and is currently being developed by RTI International as a potential pharmacotherapy to treat cocaine dependence. This study has the possibility of identifying the maximum tolerated dose in humans and a surrogate measure of JDTic pharmacodynamic (PD) activity. Data from this study will be used to plan for and define dose ranges for subsequent studies, as well as to identify potential indicators of JDTic pharmacological activity.

Conditions

Cocaine Dependence

Keywords

JDTic; cocaine dependence; kappa-opioid antagonist

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of single, escalating oral doses of JDTic in healthy male subjects

  Safety and tolerability of JDTic: clinical signs and symptoms, adverse events (AEs), vital signs, electrocardiographic parameters, clinical laboratory test results, psychomotor function assessment

  125 hours following administration of JDTic

Secondary Outcomes (2)

• Pharmacokinetics Profile

  125 hours post-dose

• To evaluate a potential surrogate measure of JDTic PD activity

  14 days after receiving JDTic

Study Arms (1)

Single dose JDTic 1 mg, 3 mg, or 10 mg

EXPERIMENTAL

Drug: JDtic

Interventions

JDtic DRUG

The planned JDTic dose levels to be evaluated are 1 mg, 3 mg, and 10 mg; however, the actual dose levels evaluated may be different, and/or additional dose levels may be added by protocol amendment, depending on the safety and PK results of the lower doses. Subjects will be admitted to the clinic the day before dosing and will be confined to the clinic for 6 nights, with safety and PK evaluations and assessments lasting approximately 125 hours following administration of study drug.

Single dose JDTic 1 mg, 3 mg, or 10 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject provides signed and dated, written informed consent before any study-specific procedures are performed, including washout of any medications. Subjects will be asked to meet the food, beverage and physical activity restrictions required for the screening visit prior to signing consent.
• Subject is a healthy adult male aged 18 to 50 years, inclusive, at the time of consent.
• Subject has a body weight of at least 50 kg and a body mass index (BMI) in the range of 18 to 30
• Subject has a negative prestudy urine drug screen and no history of use of illicit drugs within 12 months of the screening visit or other substances of abuse within 12 months of the screening visit.
• Subject has not used tobacco for at least 90 days prior to screening.
• Subject has no history of any cardiovascular disease and no clinically significant ECG results at screening.
• Subject is negative for hepatitis C (HCV) antibodies, hepatitis B (HBV) surface antigen, and human immunodeficiency virus (HIV) at screening.
• Subject is in good general health in the opinion of the Clinic Principal Investigator and as determined by medical history, physical examination, orthostatic vital signs (supine, sitting, and standing blood pressure and heart rate; supine respiratory rate and oral temperature), 12-lead ECG, and clinical laboratory tests at screening. Additionally, the subject's clinical laboratory test results must meet the following criteria:
• \- Within normal limits: Reticulocyte count
• \- Within upper limit of normal and not clinically significantly below the lower limit of normal: Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Gamma glutamyl transferase (GGT) Prothrombin time (PT) Activated partial thromboplastin time (aPTT) Serum troponin I Blood urea nitrogen (BUN) Creatinine Bilirubin, total Alkaline phosphatase Creatine kinase Lactate dehydrogenase (LDH)
• \- No clinically significant abnormalities: Sodium Protein, total Calcium Chloride Phosphorus Albumin Globulin Cholesterol Triglycerides Red blood cells (RBC) White blood cells (WBC) Hematocrit Hemoglobin Platelets Glucose Potassium WBC differential RBC indices Uric acid Urinalysis
• Subject is willing to use barrier contraception with spermicide during sexual intercourse and is also willing to not donate sperm while enrolled in this study and for at least 90 days after receiving his dose of study drug.
• Subject is willing and able to comply with study instructions and restrictions and is available to complete the study assessments as required by the protocol
• Subject is fluent in English.

You may not qualify if:

• Subject has a history or evidence of hepatic, GI, renal, respiratory, ophthalmic, cardiovascular, hematologic, endocrine/metabolic, neurologic, immunologic, oncologic, or psychiatric illness or significant abnormalities; OR other condition(s)/surgical intervention(s) known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Subject has a clinically significant abnormal ECG at screening or prior to dosing. Multiple premature atrial contractions or multiple premature ventricular contractions (PVCs), with the exception of non-clinically significant unifocal PVCs, are considered clinically significant, as are bundle branch blocks, second or third degree heart block, or any arrhythmia other than respiratory sinus arrhythmia.
• Subject has one or more ECG parameters outside the following ranges at Screening or just prior to dosing:
• Heart rate less than 55 or greater than 100 beats per minute (bpm), PR interval less than 120 or greater than 180 msec, QRS duration less than 70 or greater than 100 msec, QT interval (Bazett) greater than 420 msec
• One or more of the Subject's supine vital signs are outside the ranges specified below:
• Systolic blood pressure: 90-140 mmHg, inclusive
• Diastolic blood pressure: 60-90 mmHg, inclusive
• Heart rate: 55-100 beats per minute (bpm), inclusive
• Respiratory rate: 12-20 breaths per minute, inclusive
• Oral temperature: 97.0-99.7 degrees Fahrenheit, inclusive
• Subject has a history or current evidence of early cardiac repolarization.
• Subject has a history or family history of QT prolongation, arrhythmia, or uncontrolled hypertension.
• Subject has a history of seizure, head injury, neurosurgery or brain trauma, or a family history of nontraumatic seizure.
• Subject has an infection of any type or clinically significant abnormality identified by the screening medical or laboratory evaluations.
• Subject has consumed alcohol within 48 hours prior to the screening visit or is unwilling to discontinue alcohol consumption within 48 hours of being admitted to the clinic.

Sponsors & Collaborators

• RTI International: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Celerion Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dennis Swearingen, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 9, 2011
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)