Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression

Completed · Phase 1 · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)

Key facts

Study ID

NCT03606395

Run by

Navitor Pharmaceuticals, Inc.

People needed

80

Starts

2018-06-06

Expected to finish

2019-07-07

Last updated by the study team

2019-07-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion Criteria (Subjects in Part A or Part B):
• Subjects must not have:
• A positive pregnancy test result or be breastfeeding.
• A clinically significant illness (including chronic, persistent, or acute infection), medical/surgical procedure, or trauma within 30 days prior to screen or between screen and dose administration (Day 1).
• A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
• A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion.
• A clinically significant abnormality on physical examination, neurological examination, electrocardiogram (ECG), or laboratory evaluations at screen or between screen and dose administration (Day 1).
• Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at screen or between screen and dose administration (Day 1).
• Creatinine clearance < 60 mL/min, according to the Cockcroft-Gault equation.
• Leukocyte or neutrophil counts less than the lower limit of normal (LLN) at screen or between screen and dose administration (Day 1).
• A clinically significant vital signs abnormality at screen or between screen and dose administration (Day 1). This includes, but is not limited to, the following, in the supine position (after 10 minutes supine controlled rest): (a) systolic blood pressure > 140 mmHg, (b) diastolic blood pressure > 90 mmHg, or (c) heart rate < 45 or > 85 beats per minute.
• A corrected QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 msec for men and > 470 msec for women during controlled rest at screen or between screen and dose administration (Day 1), or family history of long-QT syndrome.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
• PR (PQ) interval shortening < 120 msec (PR < 120 msec but > 110 msec is acceptable if there is no evidence of ventricular pre-excitation).
• PR (PQ) interval prolongation (> 240 msec), intermittent second-degree (Wenckebach block while asleep or in deep rest is not exclusionary) or third-degree atrioventricular block.
• Persistent or intermittent complete bundle branch block (BBB), or intraventricular conduction delay (IVCD) with QRS > 110 msec. Subjects with QRS > 110 msec but < 115 msec are acceptable if there is no evidence of ventricular hypertrophy or pre-excitation.
• Significant (> 10%) weight loss or gain within 30 days prior to screen or between screen and dose administration (Day 1).
• A history of seizure.
• A history of clinically significant head trauma, including closed head injury with loss of consciousness.
• A history of clinically significant symptomatic orthostatic hypotension (i.e., postural syncope).
• A history of neuroleptic malignant syndrome.
• A history of chronic urinary tract infections.
• A history of cancer within 5 years prior to screen or between screen and randomization (with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin), any history of renal cell carcinoma or breast cancer, or a family history of lymphangioleiomyomatosis in association with tuberous sclerosis complex (TSC-LAM).
• Any illness or condition that, in the opinion of the investigator, (a) significantly increases the potential risk associated with the subject's participation in the study, (b) decreases the likelihood the subject will complete the study, and/or (c) may confound the results of the study.
• A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Collaborative Neuroscience Network — Long Beach, California, United States
• Synergy San Diego — San Diego, California, United States
• MD Clinical — Hallandale, Florida, United States
• Innovative Clinical Research Inc — Hialeah, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Midwest Clinical Research — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.