scholarly journals A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a SMN2 splicing modifier

2018 ◽  
Vol 85 (1) ◽  
pp. 181-193 ◽  
Author(s):  
Stefan Sturm ◽  
Andreas Günther ◽  
Birgit Jaber ◽  
Paul Jordan ◽  
Nada Al Kotbi ◽  
...  
Keyword(s):  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Phase 1 ◽  
Healthy Male ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Dose Study

Absorption, Distribution, and Excretion of the Investigational Agent Orteronel (TAK-700) in Healthy Male Subjects: A Phase 1, Open-Label, Single-Dose Study

2016 ◽  
Vol 5 (3) ◽  
pp. 180-187
Author(s):  
Ajit Suri ◽  
Sandeepraj Pusalkar ◽  
Yuexian Li ◽  
Shimoga Prakash
Keyword(s):  
Single Dose ◽  
Phase 1 ◽  
Healthy Male ◽  
Open Label ◽  
Single Dose Study ◽  
Investigational Agent ◽  
Dose Study ◽  
Male Subjects

Human metabolism of aluminium-26 and gallium-67 injected as citrates

1995 ◽  
Vol 14 (3) ◽  
pp. 287-293 ◽  
Author(s):  
ND Priest ◽  
D. Newton ◽  
JP Day ◽  
RJ Talbot ◽  
AJ Warner
Keyword(s):  
Mass Spectrometry ◽  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Renal Excretion ◽  
Whole Body ◽  
Human Metabolism ◽  
Radioactivity Measurement ◽  
Healthy Male ◽  
Body Retention ◽  
Gallium 67

1 26Al and 67Ga were given as citrates to a healthy male volunteer by intravenous injection. The retention of both tracers was studied by body radioactivity measurement. Levels in blood and excreta were determined by y-ray spectrometry and/or accelerator mass spectrometry. 2 More than half of the 26Al had left the blood after 15 min and the decline continued, leaving <1% in blood after 2 d; the losses occurred both to renal excretion and through uptake by other compartments. Estimated excre tion up to 13 d was 83% (urine) and 1.8% (faeces). Whole-body retention of 15% at 13 d declined to ∼4% at 1178 d, when the daily reduction corresponded to a bio logical half-life of 7 y, suggesting that sustained intake of dietary aluminium may lead to a progressively increas ing internal deposit. 3 The metabolism of 67Ga differed markedly from that of 26Al in all aspects studied.

Plasma Hydrazine Concentrations in Man after Isoniazid and Hydralazine Administration

1985 ◽  
Vol 4 (2) ◽  
pp. 195-202 ◽  
Author(s):  
I.A. Blair ◽  
R. Mansilla Tinoco ◽  
M.J. Brodie ◽  
R.A. Clare ◽  
C.T. Dollery ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Gas Chromatography ◽  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Limit Of Detection ◽  
Gas Chromatography Mass Spectrometry ◽  
Healthy Male ◽  
Slow Acetylator ◽  
Hypertensive Patients ◽  
Stable Isotope Dilution

1 By using a specific sensitive stable-isotope dilution gas chromatography-mass spectrometry (GC-MS) assay, hydrazine was detected in the plasma of eight healthy male volunteer subjects taking isoniazid (300 mg daily) for 2 weeks. 2 Accumulation of hydrazine occurred in slow-acetylator phenotypes. 3 Hydrazine was also detected in the plasma of eight out of 14 hypertensive patients treated chronically with hydralazine (200 mg daily). 4 However, the concentrations of hydrazine observed were much lower than in the isoniazid study and were close to the limit of detection. 5 As hydrazine is hepatotoxic, mutagenic and carcinogenic in animals, its presence in human plasma has important toxicological implications.

Pharmacokinetics of the anticoagulant14C-DX-9065a in the healthy male volunteer after a single intravenous dose

Xenobiotica ◽  
2000 ◽  
Vol 30 (5) ◽  
pp. 515-521 ◽  
Author(s):  
N. Murayama ◽  
H. McMahon ◽  
C. G. Young ◽  
N. W. McCracken ◽  
Y. Okamura ◽  
...  
Keyword(s):  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Intravenous Dose ◽  
Single Intravenous Dose ◽  
Healthy Male

Abstract 1291: A phase 1 open-label single-radiolabeled dose study of PF299804 in healthy male volunteers

2011 ◽  
Author(s):  
Carlo L. Bello ◽  
Evan Smith ◽  
Ana Ruiz ◽  
Grace Ni ◽  
Carol McCormick ◽  
...  
Keyword(s):  
Phase 1 ◽  
Healthy Male ◽  
Open Label ◽  
Healthy Male Volunteers ◽  
Male Volunteers ◽  
Dose Study

Pharmacokinetics of14C-delmopinol in the healthy male volunteer

Xenobiotica ◽  
1998 ◽  
Vol 28 (11) ◽  
pp. 1075-1081 ◽  
Author(s):  
B. ERIKSSON
Keyword(s):  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Healthy Male

Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis

2020 ◽  
Vol 36 (1) ◽  
pp. 133-142
Author(s):  
Winnie Sohn ◽  
Isidro B. Salusky ◽  
Claus Peter Schmitt ◽  
Christina Taylan ◽  
Johan Vande Walle ◽  
...  
Keyword(s):  
Single Dose ◽  
Secondary Hyperparathyroidism ◽  
Pediatric Patients ◽  
Phase 1 ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Single Dose Study ◽  
Dose Study

scholarly journals Reference Interval of Clinical Laboratory Data of Young Healthy Male Volunteer in the Phase I Clinical Study.

1996 ◽  
Vol 27 (2) ◽  
pp. 469-479
Author(s):  
Junichi AZUMA ◽  
Yonezou SETO ◽  
Isamu YAMAMOTO ◽  
Moritaka OGURA ◽  
Noriko MOTIZUKI ◽  
...  
Keyword(s):  
Clinical Study ◽  
Phase I ◽  
Male Volunteer ◽  
Healthy Male Volunteer ◽  
Clinical Laboratory ◽  
Laboratory Data ◽  
Reference Interval ◽  
Healthy Male
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