Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-naïve healthy volunteers

2017 ◽  
Vol 33 (11) ◽  
pp. 1915-1920 ◽  
Author(s):  
Richard Rauck ◽  
D. Alexander Oh ◽  
Neha Parikh ◽  
Christian Koch ◽  
Neil Singla ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Fentanyl Citrate ◽  
Dose Study ◽  
Single Ascending Dose Study

scholarly journals A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme

2020 ◽  
Vol 16 (S9) ◽  
Author(s):  
William Kielbasa ◽  
Krista M Phipps ◽  
James Tseng ◽  
Fanni Natanegara ◽  
Eden Cheng ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Dose Study ◽  
Single Ascending Dose Study

Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a multiple ascending dose study in opioid-naïve healthy volunteers

2017 ◽  
Vol 33 (11) ◽  
pp. 1921-1933 ◽  
Author(s):  
Richard L. Rauck ◽  
D. Alexander Oh ◽  
Neil Singla ◽  
Christian Koch ◽  
Neha Parikh ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Fentanyl Citrate ◽  
Dose Study

A single ascending-dose study of muscle regulator ace-031 in healthy volunteers

2012 ◽  
Vol 47 (3) ◽  
pp. 416-423 ◽  
Author(s):  
Kenneth M. Attie ◽  
Niels G. Borgstein ◽  
Yijun Yang ◽  
Carolyn H. Condon ◽  
Dawn M. Wilson ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Dose Study ◽  
Single Ascending Dose Study

Safety, Pharmacokinetic, and Pharmacodynamic Evaluations of PI-2301, a Potent Immunomodulator, in a First-in-Human, Single-Ascending-Dose Study in Healthy Volunteers

2011 ◽  
Vol 51 (5) ◽  
pp. 649-660 ◽  
Author(s):  
Joseph Kovalchin ◽  
Jeffrey Krieger ◽  
Kathy Collins ◽  
Michelle Genova ◽  
Michael Augustyniak ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Dose Study ◽  
Single Ascending Dose Study

scholarly journals Single-Dose Safety and Pharmacokinetics of ST-246, a Novel Orthopoxvirus Egress Inhibitor

2008 ◽  
Vol 52 (5) ◽  
pp. 1721-1727 ◽  
Author(s):  
Robert Jordan ◽  
Deborah Tien ◽  
Tove' C. Bolken ◽  
Kevin F. Jones ◽  
Shanthakumar R. Tyavanagimatt ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Healthy Human ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Volunteers ◽  
Dose Study ◽  
Exposure Levels ◽  
Oral Doses ◽  
First Time ◽  
Single Ascending Dose Study

ABSTRACT ST-246 is a novel, potent orthopoxvirus egress inhibitor that is being developed to treat pathogenic orthopoxvirus infections of humans. This phase I, double-blind, randomized, placebo-controlled single ascending dose study (first time with humans) was conducted to determine the safety, tolerability, and pharmacokinetics of ST-246 in healthy human volunteers. ST-246 was administered in single oral doses of 500, 1,000, and 2,000 mg to fasting healthy volunteers and 1,000 mg to nonfasting healthy volunteers. ST-246 was generally well tolerated with no serious adverse events, and no subject was withdrawn from the study due to ST-246. The most commonly reported drug-related adverse event was neutropenia, which was found, upon further analysis, not to be treatment related. ST-246 was readily absorbed following oral administration with mean times to maximum concentration from 2 h to 3 h. Absorption was greater in nonfasting volunteers than in fasting volunteers. Administration of ST-246 resulted in exposure levels predicted to be sufficient for inhibiting orthopoxvirus replication compared to exposure levels in nonhuman primates in which ST-246 protected animals from lethal orthopoxvirus infection.

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