FASTMAS (Fast-Fail Trials in Mood and Anxiety Spectrum Disorders) Kappa Opioid Receptor Phase 1 Study

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The available treatments for patients with mood and anxiety spectrum disorders have significant limitations. This study will contribute significantly to public health by taking steps to address these limitations by aiding in the interpretation of a study that: 1) tests a promising new treatment for mood and anxiety spectrum disorders; 2) evaluates a potential target in the brain which could serve as the basis for development of additional new candidate compounds for the treatment of patients with mood and anxiety spectrum disorders; 3) establishes more expeditious methods for evaluating potential new therapies for patients with mood and anxiety spectrum disorders; and 4) specifically establishes methods for the development of new therapies targeting anhedonia, an important RDoC (Research Domain Criteria) endpoint.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Andrew Krystal
• Collaborator: Yale University
• Treatments: Analgesics, Opioid; Aticaprant

Criteria

Inclusion Criteria:

• Age 21 through 65 years of age

• Body mass index 19 through 30 lbs/in2

• Reliable and willing to be available for the duration of the study

• Willing and able to give written informed consent to participate

• Able to understand and comply with instructions

• If female of childbearing potential, must agree to use dual methods of contraception and be willing and able to continue contraception for 6 weeks after the last dose of study drug. Females using oral contraception must have started using it at least 2 months prior to the Baseline Visit

• If male of childbearing potential, must have undergone surgical sterilization (such as a vasectomy) or agree to use a condom used with a spermicide during participation in the study and for 1 month afterward

Exclusion Criteria:

• Any clinically significant abnormality of any of the hematology, clinical, chemistry, or urine drug tests

• Magnetic resonance imaging contraindications at 3 Tesla (e.g., ferromagnetic implants or shrapnel or other incompatibilities)

• Any clinically significant abnormality of the 12-lead ECG; QTc (corrected QT) interval recorded on screening or predose greater than 450 msec

• Any clinically significant history of neurologic disease, cancer, or cardiac, respiratory, metabolic, hepatic, renal, gastrointestinal (except appendectomy), dermatological, venereal, hematological disorder or disease

• Any clinically significant history of Axis I psychiatric disorder, or history of attempted suicide

• History of seeking advice from a physician or counselor for abuse or misuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse, for example, solvents

• Any current or previous recreational use of Class A drugs such as opiates, cocaine, ecstasy, LSD (Lysergic acid diethylamide), and amphetamines (Class B)

• Positive drugs-of-abuse test result at initial exam or at any time during the study

• An alcoholic intake greater than 7 units per week or unwillingness to stop alcohol consumption for the duration of the study {1 unit = 8 g ethanol (250 mL of beer, 1 glass wine [100 mL], 1 measure spirits [30 mL])}

• Use of prescribed medication within 30 days of the first study day, or nonprescription medication including herbal remedies except standard dose vitamin supplements and acetaminophen (up to 4 g/day) within 15 days of the first study drug administration, or any medication that would need to be continued during the study

• Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug other than LY2456302 during the course of this study

• Any smoking of cigarettes or use of any nicotine containing products within the last month or at any time during the study

• History of blood donation in the last 3 months

• History of severe allergies or multiple adverse drug reactions

• Known hypersensitivity to LY2456302

• Any history of a clinically significant gastrointestinal condition

• Any other condition that in the opinion of the investigator would preclude participation in the study

• Pregnant or lactating

• History of peptic ulcer disease or gastritis or positive urea breath test