PT150, a novel competitive glucocorticoid receptor (GR) antagonist, has proven safe in animal models, healthy volunteers, and people with depression. Our study is the first to investigate PT150’s safety with alcohol use. The primary objective of this study was to evaluate pharmacodynamic interactions between ethanol and PT150 in healthy subjects. This single-site, Phase I pilot trial consisted of community-recruited, healthy, alcohol-experienced participants aged 21–64 years. Of 32 participants screened, 11 were enrolled and randomized, one of which withdrew before intervention. PT150 (900 mg/day) was administered orally to all participants for five days. All participants received two beverage challenges on Day 1 (before PT150 administration) and Day 5 (after PT150 administration). On challenge days, they received both alcohol (16% ethanol) and placebo (1% ethanol) beverages in random order. Primary outcomes included breath alcohol level, blood pressure, heart rate, adverse events, and electrocardiogram changes. There were no statistically significant differences in vital signs or estimated blood alcohol concentrations between PT150 non-exposed and exposed groups during the ethanol challenge. There were no clinically significant abnormal electrocardiograms or serious adverse events. These data show that administration of PT150 with concurrent alcohol use is safe and well-tolerated. This study supports a future pharmacokinetic interaction study between PT150 and alcohol.Trial Registration ClinicalTrials.gov Identifier: NCT03548714.
A male infant of gestational age 34 and two-seventh weeks presented at birth with severe pancytopenia. He was born via cesarian section for nonreassuring fetal heart tracings to a 22-year-old primigravida woman with good prenatal care. Pregnancy was complicated by asymptomatic bacteriuria with Escherichia coli, bacterial vaginosis, mild anemia, and the development of intrauterine growth restriction. Routine maternal testing, including for HIV, hepatitis B, syphilis, rubella, and antibody screen as well as gonococcal and chlamydia testing, was negative. The infant's mother was admitted to labor and delivery for poor fetal growth 2 days prior to delivery. The infant's father was 21 years old and had a history of hypertension and obesity. Family history was significant for a paternal great-grandaunt diagnosed with pancytopenia in adulthood and a maternal great grandmother diagnosed with myelocytic leukemia in her 60s. The infant's first cousin had an ocular anomaly, and another first cousin had a "forearm bone problem." There was no known consanguinity. At delivery, the infant was vigorous with APGAR scores of 9 and 9 at 1 and 5 minutes respectively, and the birth weight was 2.1 kg. He was pale, and after warming and drying, he developed bruising and petechiae on his body. He had no obvious dysmorphic features, although proximally placed, digitalized thumbs were observed (Figure 1). A complete blood count at 45 minutes of life showed a white blood cell count of 1.7 × 10 3 /µL, a hemoglobin concentration of 5.2 g/dL, a hematocrit of 14.6%, and a platelet count of 9000/µL. The results of a coagulation panel were within normal limits. Blood culture specimens were drawn, and the infant received intramuscular vitamin K, intravenous ampicillin, and gentamicin. A repeat blood count confirmed pancytopenia, and he was transferred to our facility for further evaluation and management of the pancytopenia. An evaluation for an infectious etiology of pancytopenia was negative, including herpes simplex virus, cytomegalovirus (CMV), adenovirus, parvovirus, enterovirus, syphilis, and toxoplasmosis. An ophthalmological exam for CMV retinitis was negative.
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