scholarly journals Four phase 1 trials to evaluate the safety and pharmacokinetic profile of single and repeated dosing of SCO‐101 in adult male and female volunteers

2020 ◽  
Vol 127 (4) ◽  
pp. 329-337 ◽  
Author(s):  
Troels K. Bergmann ◽  
Tore B. Stage ◽  
Jan Stenvang ◽  
Palle Christophersen ◽  
Thomas A. Jacobsen ◽  
...  
Keyword(s):  
Adult Male ◽  
Phase 1 ◽  
Pharmacokinetic Profile ◽  
Male And Female ◽  
Phase 1 Trials ◽  
Repeated Dosing

scholarly journals Pharmacokinetics and Safety of CXA-101, a New Antipseudomonal Cephalosporin, in Healthy Adult Male and Female Subjects Receiving Single- and Multiple-Dose Intravenous Infusions

2010 ◽  
Vol 54 (8) ◽  
pp. 3427-3431 ◽  
Author(s):  
Yigong Ge ◽  
M. J. Whitehouse ◽  
Ian Friedland ◽  
George H. Talbot
Keyword(s):  
Multiple Dose ◽  
Bacterial Infections ◽  
Phase 1 ◽  
Study Drug ◽  
Pharmacokinetic Profile ◽  
Male And Female ◽  
Healthy Adult Male ◽  
Clinically Significant ◽  
Favorable Safety ◽  
Female Subjects

ABSTRACT CXA-101 is a novel, broad-spectrum cephalosporin with excellent antipseudomonal activity. A Phase 1 study was performed to determine the safety, tolerability, and pharmacokinetics of CXA-101 after single- and multiple-dose intravenous administration over 1 h to healthy male and female subjects. In part 1 of the study, five cohorts of eight subjects each (six receiving CXA-101 and two receiving a placebo) received single ascending doses of 250, 500, 1,000, 1,500, and 2,000 mg. In part 2, cohorts 1 and 2 received 500 mg and 1,000 mg, respectively, every 8 h, and cohort 3 received 1,500 mg every 12 h; each cohort received dosing for 10 days. Standard safety and tolerability assessments were performed. Blood and urine pharmacokinetic samples were assayed by a validated bioanalytical method and analyzed using standard noncompartmental methodology. All 64 subjects completed dosing; none withdrew from the study. Drug-related systemic adverse events were infrequent and mild. Mild, non-treatment-limiting infusion site events occurred during multiple-dose administration. No clinically significant laboratory or electrocardiographic finding or dose-limiting toxicity was observed. CXA-101 exhibited dose-linear pharmacokinetics; the mean plasma half-life was ∼2.3 h. More than 90% of the administered dose was eliminated unchanged through renal excretion. In summary, CXA-101 administered as a 1-hour infusion was generally safe and well tolerated in single doses up to 2,000 mg and in multiple doses up to 3 g daily over 10 days. The favorable safety and predictable pharmacokinetic profile of CXA-101 support its continuing clinical development for the treatment of serious bacterial infections.

Effect of In-Utero Exposure to High Dose Diethylstilbestrol on Intervertebral Disk in Adult Male and Female Progeny

2012 ◽  
Vol 2 (1_suppl) ◽  
pp. s-0032-1319931-s-0032-1319931
Author(s):  
S. Al Rowas ◽  
R. Gawri ◽  
R. Haddad ◽  
A. Almaawi ◽  
L. E. Chalifour ◽  
...  
Keyword(s):  
Adult Male ◽  
In Utero ◽  
Intervertebral Disk ◽  
In Utero Exposure ◽  
High Dose ◽  
Female Progeny ◽  
Male And Female

Early Life Exposure to Antibiotic Alters Energy Balance during Chronic High-Fat Feeding in Adult Male and Female Mice

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 1999-P ◽  
Author(s):  
HYE LIM NOH ◽  
SUJIN SUK ◽  
RANDALL H. FRIEDLINE ◽  
KUNIKAZU INASHIMA ◽  
DUY A. TRAN ◽  
...  
Keyword(s):  
Energy Balance ◽  
Adult Male ◽  
Early Life ◽  
High Fat ◽  
Male And Female ◽  
Female Mice ◽  
Early Life Exposure ◽  
Fat Feeding

Placental treatment improves cardiac tolerance to ischemia/reperfusion insult in adult male and female offspring exposed to prenatal hypoxia

2021 ◽  
Vol 165 ◽  
pp. 105461
Author(s):  
Nataliia Hula ◽  
Floor Spaans ◽  
Jennie Vu ◽  
Anita Quon ◽  
Raven Kirschenman ◽  
...  
Keyword(s):  
Adult Male ◽  
Ischemia Reperfusion ◽  
Female Offspring ◽  
Prenatal Hypoxia ◽  
Male And Female

scholarly journals Sexual dimorphic role of the glucocorticoid receptor in chronic muscle pain produced by early-life stress

2021 ◽  
Vol 17 ◽  
pp. 174480692110113
Author(s):  
Paul G Green ◽  
Pedro Alvarez ◽  
Jon D Levine
Keyword(s):  
Glucocorticoid Receptor ◽  
Adult Male ◽  
Life Stress ◽  
Early Life ◽  
Glucocorticoid Receptors ◽  
Early Life Stress ◽  
Nociceptive Threshold ◽  
Male And Female ◽  
Mechanical Nociceptive Threshold

Fibromyalgia and other chronic musculoskeletal pain syndromes are associated with stressful early life events, which can produce a persistent dysregulation in the hypothalamic-pituitary adrenal (HPA) stress axis function, associated with elevated plasm levels of corticosterone in adults. To determine the contribution of the HPA axis to persistent muscle hyperalgesia in adult rats that had experienced neonatal limited bedding (NLB), a form of early-life stress, we evaluated the role of glucocorticoid receptors on muscle nociceptors in adult NLB rats. In adult male and female NLB rats, mechanical nociceptive threshold in skeletal muscle was significantly lower than in adult control (neonatal standard bedding) rats. Furthermore, adult males and females that received exogenous corticosterone (via dams’ milk) during postnatal days 2–9, displayed a similar lowered mechanical nociceptive threshold. To test the hypothesis that persistent glucocorticoid receptor signaling in the adult contributes to muscle hyperalgesia in NLB rats, nociceptor expression of glucocorticoid receptor (GR) was attenuated by spinal intrathecal administration of an oligodeoxynucleotide (ODN) antisense to GR mRNA. In adult NLB rats, GR antisense markedly attenuated muscle hyperalgesia in males, but not in females. These findings indicate that increased corticosterone levels during a critical developmental period (postnatal days 2–9) produced by NLB stress induces chronic mechanical hyperalgesia in male and female rats that persists in adulthood, and that this chronic muscle hyperalgesia is mediated, at least in part, by persistent stimulation of glucocorticoid receptors on sensory neurons, in the adult male, but not female rat.

Hepatic effects of a highly purified PCB 180 in adult male and female Sprague–Dawley rats

2008 ◽  
Vol 180 ◽  
pp. S39-S40
Author(s):  
Robert Roos ◽  
Patrik Andersson ◽  
Päivi Heikkinen ◽  
Hans-Joachim Schmitz ◽  
Leo van der Ven ◽  
...  
Keyword(s):  
Adult Male ◽  
Sprague Dawley ◽  
Male And Female ◽  
Sprague Dawley Rats
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