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Evaluation of safety and pharmacokinetics of sodium 2,2 dimethylbutyrate, a novel short chain fatty acid derivative, in a phase 1, double-blind, placebo-controlled, single-dose, and repeat-dose studies in healthy volunteers.

Perrine SP, Wargin WA, Boosalis MS, Wallis WJ, Case S, Keefer JR, Faller DV, Welch WC, Berenson RJ.

J Clin Pharmacol. 2011 Aug;51(8):1186-94. doi: 10.1177/0091270010379810. Epub 2011 Mar 21.


A phase 1/2 trial of HQK-1001, an oral fetal globin inducer, in sickle cell disease.

Kutlar A, Ataga K, Reid M, Vichinsky EP, Neumayr L, Blair-Britt L, Labotka R, Glass J, Keefer JR, Wargin WA, Berenson R, Perrine SP.

Am J Hematol. 2012 Nov;87(11):1017-21. doi: 10.1002/ajh.23306. Epub 2012 Aug 7.


A dose-escalation phase IIa study of 2,2-dimethylbutyrate (HQK-1001), an oral fetal globin inducer, in sickle cell disease.

Kutlar A, Reid ME, Inati A, Taher AT, Abboud MR, El-Beshlawy A, Buchanan GR, Smith H, Ataga KI, Perrine SP, Ghalie RG.

Am J Hematol. 2013 Nov;88(11):E255-60. doi: 10.1002/ajh.23533. Epub 2013 Oct 3.


A double-blind, placebo-controlled phase II study of the efficacy and safety of 2,2-dimethylbutyrate (HQK-1001), an oral fetal globin inducer, in sickle cell disease.

Reid ME, El Beshlawy A, Inati A, Kutlar A, Abboud MR, Haynes J Jr, Ward R, Sharon B, Taher AT, Smith W, Manwani D, Ghalie RG.

Am J Hematol. 2014 Jul;89(7):709-13. doi: 10.1002/ajh.23725. Epub 2014 Apr 15.


A randomized phase I/II trial of HQK-1001, an oral fetal globin gene inducer, in β-thalassaemia intermedia and HbE/β-thalassaemia.

Fucharoen S, Inati A, Siritanaratku N, Thein SL, Wargin WC, Koussa S, Taher A, Chaneim N, Boosalis M, Berenson R, Perrine SP.

Br J Haematol. 2013 May;161(4):587-93. doi: 10.1111/bjh.12304. Epub 2013 Mar 27.


Safety, tolerability, and pharmacokinetics of KNS-760704 (dexpramipexole) in healthy adult subjects.

Bozik ME, Mather JL, Kramer WG, Gribkoff VK, Ingersoll EW.

J Clin Pharmacol. 2011 Aug;51(8):1177-85. doi: 10.1177/0091270010379412. Epub 2010 Oct 19.


A short-term trial of butyrate to stimulate fetal-globin-gene expression in the beta-globin disorders.

Perrine SP, Ginder GD, Faller DV, Dover GH, Ikuta T, Witkowska HE, Cai SP, Vichinsky EP, Olivieri NF.

N Engl J Med. 1993 Jan 14;328(2):81-6.


Single-dose pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 in healthy subjects.

Sinha VP, Choi SL, Soon DK, Mace KF, Yeo KP, Lim ST, Howey DC.

J Clin Pharmacol. 2014 Jul;54(7):792-9. doi: 10.1002/jcph.276. Epub 2014 Feb 13.


Pharmacokinetics, pharmacodynamics, and tolerability of the dipeptidyl peptidase IV inhibitor LC15-0444 in healthy Korean men: a dose-block-randomized, double-blind, placebo-controlled, ascending single-dose, Phase I study.

Lim KS, Kim JR, Choi YJ, Shin KH, Kim KP, Hong JH, Cho JY, Shin HS, Yu KS, Shin SG, Kwon OH, Hwang DM, Kim JA, Jang IJ.

Clin Ther. 2008 Oct;30(10):1817-30. doi: 10.1016/j.clinthera.2008.10.013.


Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: a Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects.

Sarashina A, Sesoko S, Nakashima M, Hayashi N, Taniguchi A, Horie Y, Graefe-Mody EU, Woerle HJ, Dugi KA.

Clin Ther. 2010 Jun;32(6):1188-204. doi: 10.1016/j.clinthera.2010.06.004.


Extended therapy with intravenous arginine butyrate in patients with beta-hemoglobinopathies.

Sher GD, Ginder GD, Little J, Yang S, Dover GJ, Olivieri NF.

N Engl J Med. 1995 Jun 15;332(24):1606-10.


Safety, pharmacokinetics, and pharmacodynamics of CHF 3381, a novel N-methyl-D-aspartate antagonist, after single oral doses in healthy subjects.

Tarral A, Dostert P, Guillevic Y, Fabbri L, Rondelli I, Mariotti F, Imbimbo BP.

J Clin Pharmacol. 2003 Aug;43(8):901-11.


Pharmacokinetics of 8-hour intravenous infusion of NXY-059: a phase I, randomized, double-blind (within dose panels), placebo-controlled study in healthy Chinese volunteers.

Cheng YF, Jiang J, Hu P, Reinholdsson I, Guo W, Asenblad N, Nilsson D.

Clin Ther. 2008 Dec;30(12):2342-53. doi: 10.1016/j.clinthera.2008.12.013.


Pharmacokinetics of Ferric Pyrophosphate Citrate, a Novel Iron Salt, Administered Intravenously to Healthy Volunteers.

Pratt RD, Swinkels DW, Ikizler TA, Gupta A.

J Clin Pharmacol. 2017 Mar;57(3):312-320. doi: 10.1002/jcph.819. Epub 2016 Oct 3.


Safety and pharmacokinetics of NXN-188 after single and multiple doses in five phase I, randomized, double-blind, parallel studies in healthy adult volunteers.

Vaughan D, Speed J, Medve R, Andrews JS.

Clin Ther. 2010 Jan;32(1):146-60. doi: 10.1016/j.clinthera.2010.01.006.


Safety, tolerability, pharmacokinetics, and pharmacodynamics of fimasartan following single and repeated oral administration in the fasted and fed states in healthy subjects.

Chi YH, Lee H, Paik SH, Lee JH, Yoo BW, Kim JH, Tan HK, Kim SL.

Am J Cardiovasc Drugs. 2011 Oct 1;11(5):335-46. doi: 10.2165/11593840-000000000-00000.


Safety, Tolerability, and Pharmacokinetic Properties of Intravenous Delafloxacin After Single and Multiple Doses in Healthy Volunteers.

Hoover R, Hunt T, Benedict M, Paulson SK, Lawrence L, Cammarata S, Sun E.

Clin Ther. 2016 Jan 1;38(1):53-65. doi: 10.1016/j.clinthera.2015.11.019. Epub 2015 Dec 21.


Pharmacokinetics, safety, and tolerability of GLPG0259, a mitogen-activated protein kinase-activated protein kinase 5 (MAPKAPK5) inhibitor, given as single and multiple doses to healthy male subjects.

Namour F, Vanhoutte FP, Beetens J, Blockhuys S, De Weer M, Wigerinck P.

Drugs R D. 2012 Sep 1;12(3):141-63. doi: 10.2165/11633120-000000000-00000.


First Human Study of the Investigational Sedative and Anesthetic Drug AZD3043: A Dose-Escalation Trial to Assess the Safety, Pharmacokinetics, and Efficacy of a 30-Minute Infusion in Healthy Male Volunteers.

Kalman S, Koch P, Ahlén K, Kanes SJ, Barassin S, Björnsson MA, Norberg Å.

Anesth Analg. 2015 Oct;121(4):885-93. doi: 10.1213/ANE.0000000000000831.


Hydroxyurea-induced HbF production in anemic primates: augmentation by erythropoietin, hematopoietic growth factors, and sodium butyrate.

McDonagh KT, Dover GJ, Donahue RE, Nathan DG, Agricola B, Byrne E, Nienhuis AW.

Exp Hematol. 1992 Nov;20(10):1156-64.


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