Phase I: Safety, Tolerability, Pharmacodynamic and Interaction Trials

Beuzen JN, Taylor N, Wesnes KA, Wood A (1999). A comparison of the effects of olanzapine, haloperidol and placebo on cognitive and psychomotor functions in healthy elderly volunteers. Journal of Psychopharmacology. 13: 152-158.

 

Dunbar G, Boeijinga PH, Demazieres A, Cisterni C, Kuchibhatla R, Wesnes KA, Luthringer R (2007). Effects of TC-1734 (AZD3480), a selective neuronal nicotinic receptor agonist, on cognitive performance and the EEG of young healthy male volunteers. Psychopharmacology. 191: 919-929. 

 

Dunbar G, Kuchibhatla R (2006). Cognitive enhancement in man with Ispronicline, a nicotinic partial agonist. Journal of Molecular Neuroscience. 30: 169–172. 

 

Hanks GW (1995). Morphine sans morpheus. Lancet 346: 652-3.

 

Hanks GW, O'Neill WM, Simpson PM, Wesnes KA (1995). The cognitive and psychomotor effects of opioid analgesics. II. A randomized controlled trial of single doses of morphine, lorazepam and placebo in healthy subjects. European Journal of Clinical Pharmacology. 48: 455-460.

 

Hendriks V, van den Brink W, Blanken P, Bosman I, van Ree J (2001). Heroin self-administration by means of ‘chasing the dragon’: pharmacodynamics and bioavailability of inhaled heroin. European Neuropsychopharmacology. 11: 241-252. 

 

Holland RL, Wesnes KA, Dietrich B (1994). Single dose human pharmacology of umespirone. European Journal of Clinical Pharmacology. 46: 461-468.

 

Kastberg H, Jansen JA, Cole G, Wesnes KA (1998). Tiagabine; Absence of kinetic or dynamic interactions with ethanol. Drug Metabolism and Drug Interactions. 14: 259-273.

 

Kay GG, Wesnes KA (2005). Pharmacodynamic effects of darifenacin, a muscarinic M3 selective receptor antagonist for the treatment of overactive bladder, in healthy volunteers. BJU International. 96: 1055-1062.

 

Kitagawa H, Takenouchi T, Azuma R, Wesnes KA, Kramer WG, Clody DE, Burnett AL (2003). Safety, pharmacokinetics, and effects on cognitive function of multiple doses of GTS-21 in healthy, male volunteers. Neuropsychopharmacology. 28: 542-551. 

 

Kleinbloesem CH, Jaquet-Muller F, al-Hamdan Y, Baldauf C, Gisclon L, Wesnes K, Curtin CR, Stubbs RJ, Walker SA, Brunner-Ferber F (1996). Incremental dosage of the new antipsychotic mazapertine induces tolerance to cardiovascular and cognitive effects in healthy men. Clinical

Pharmacology and Therapeutics. 59: 675-685.

 

Legangneux E, McEwen J, Wesnes KA, Bergougnan L, Miget N, Canal M, L'Heritier C, Pinquier JL, Rosenzweig P (2000). The acute effects of amisulpride (50 mg and 200 mg) and haloperidol (2 mg) on cognitive function in healthy elderly volunteers. Journal of Psychopharmacology. 14: 164-171.

 

Lipton RB, Kolodner K, Wesnes KA (2005). Assessment of cognitive function of the elderly population: effects of darifenacin. The Journal of Urology. 173: 493-498.

 

Mason BJ, Goodman AM, Dixon RM, Hameed MH, Hulot T, Wesnes KA, Hunter JA, Boyeson MG (2002). A pharmacokinetic and pharmacodynamic drug interaction study of acamprosate and naltrexone. Neuropsychopharmacology. 27:  596-606.

 

Modi NB, Dresser M, Desai D, Edgar C, Wesnes KA (2007). Dapoxetine has no pharmacokinetic or cognitive interactions with ethanol in healthy male volunteers. Journal of Clinical Pharmacology. 47: 315-322.

 

Morain P, Lestage P, De Nanteuil G, Jochemsen R, Robin J-L, Guez D, Boyer P-A (2002). S 17092: a prolyl endopeptidase inhibitor as a potential therapeutic drug for memory impairment. Preclinical and clinical studies. CNS Drug Reviews. 8: 31-52.  

 

Morain P, Robin L, Nanteuil G De, Jochemsen R, Heidet V (2000). Pharmacodynamic and pharmacokinetic profile of S 17092, a new orally active prolyl endopeptidase inhibitor, in elderly healthy volunteers. A phase I study. British Journal of Clinical Pharmacology. 50:350-359. 

 

Nathan PJ et al. (2012) Multiple-dose safety, pharmacokinetics, and pharmacodynamics of the mu-opioid receptor inverse agonist GSK1521498. Journal of Clinical Pharmacology 52: 1456-1467.

 

Neave N, Reid C, Scholey AB, Thompson JM, Moss M, Ayre G, Wesnes KA, Girdler NM (2000). Dose-dependent effects of flumazenil on cognition, mood, and cardio-respiratory physiology in healthy volunteers. British Dental Journal. 189: 668-674.

 

O'Neill WM, Hanks GW, Simpson PM, Fallon MT, Jenkins E, Wesnes KA (2000). The cognitive and psychomotor effects of morphine in healthy subjects: a randomized controlled trial of repeated (four) oral doses of dextropropoxyphene, morphine, lorazepam and placebo. Pain. 85: 209-215.

 

O'Neill WM, Hanks GW, White L, Simpson PM, Wesnes KA (1995). The cognitive and psychomotor effects of opioid analgesics. I. A randomised controlled trial of single doses of dextropropoxyphene, lorazepam and placebo in healthy subjects. European Journal of Clinical Pharmacology. 48: 447-453.

 

Otmani S, Demazieres A, Staner C, Jacob N, Nir T, Zisapel N, Staner L (2008). Effects of prolonged-release melatonin, zolpidem, and their combination on psychomotor functions, memory recall, and driving skills in healthy middle aged and elderly volunteers. Human Psychopharmacology 23: 693-705. 

 

Palmer C, Ellis K, O'Neil B, Croft R, Leung C, Oliver C, Wesnes KA, Nathan P (2007). The cognitive effects of modulating the glycine site of the NMDA receptor with high-dose glycine in healthy controls. Human Psychopharmacology. 23: 151-159.

 

Parrott AC, Wesnes KA (1987). Promethazine, scopolamine and cinnarizine: comparative time course of psychological performance effects. Psychopharmacology. 92: 513-519.

 

Pomara N, Willoughby L, Wesnes KA, Greenblatt DJ, Sidtis JJ (2005). Apolipoprotein E epsilon4 allele and lorazepam effects on memory in high-functioning older adults. Archives of General Psychiatry. 62: 209-216.

 

Pomara N, Willoughby LM, Hashim A, Sershen H, Sidtis JJ, Wesnes KA, Greenblatt DJ, Lajtha A (2004). Effects of acute lorazepam administration on aminergic activity in normal elderly subjects: relationship to performance effects and apolipoprotein genotype. Neurochemical Research. 29: 1391-1398.

 

Pomara N, Willoughby LM, Sidtis JJ, Doraiswamy PM, Wesnes KA, Cooper TB, Greenblatt DJ (2004). Baseline plasma GABA: its relationship to the adverse effects of acute lorazepam administration on cognition in the elderly. Neurochemical Research. 29: 2311-2315.

 

Pomara N, Willoughby LM, Wesnes KA, Sidtis JJ (2004). Increased anticholinergic challenge-induced memory impairment associated with the APOE-epsilon4 allele in the elderly: a controlled pilot study. Neuropsychopharmacology. 29: 403-409.

 

Rapeport WG, Muirhead DC, Williams SA, Cross M, Wesnes KA (1996). Absence of effect of sertraline on the pharmacokinetics and pharmacodynamics of phenytoin. Journal of Clinical Psychiatry. 57: 24-28.

 

Rapeport WG, Williams SA, Muirhead DC, Dewland PM, Tanner T, Wesnes KA (1996). Absence of a sertraline-mediated effect on the pharmacokinetics and pharmacodynamics of carbamazepine. Journal of Clinical Psychiatry. 57: 20-23.

 

Ruwe FJL, Smulders RA, Kleijn HJ, Hartmans HLA, Sitsen JMA (2001). Mirtazapine and paroxetine: a drug-drug interaction study in healthy subjects. Human Psychopharmacology - Clinical and Experimental. 16: 449-459.

 

Sitsen J, Maris F, Timmer C  (2001). Drug-drug interaction studies with mirtazapine and carbamazepine in healthy male subjects. Eur J Drug Metab Pharmacokinet 26: 109-121.

 

Shah J, Wesnes KA, Kovelesky RA, Henney HR (2006). Effects of food on the single-dose pharmacokinetics/ pharmacodynamics of tizanidine capsules and tablets in healthy volunteers. Clinical Therapeutics. 28: 1308-1317.

 

Sitsen JMA, Maris FA, Timmer CJ (2001). Drug-drug interaction studies with mirtazapine and carbamazepine in healthy male subjects. European Journal of Drug Metabolism and Pharmacokinetics. 26: 109-121.

 

Sitsen JMA, Voortman G, Timmer CJ (2000). Pharmacokinetics of mirtazapine and lithium in healthy male subjects. Journal of Psychopharmacology. 14: 172-176.

 

van Harten J, Stevens LA, Raghoebar M, Holland RL, Wesnes KA, Cournot A (1992). Fluvoxamine does not interact with alcohol or potentiate alcohol-related impairment of cognitive function. Clinical Pharmacology and Therapeutics. 5: 427-435.

 

Wesnes KA, Annas P, Edgar CJ, Deeprose C, Karlsten R, Philipp A, Kalliomäki J,  Segerdahl M (2010). Nabilone produces marked impairments to cognitive function and changes in subjective state in healthy volunteers. Journal of Psychopharmacology 24: 1659-1669.

 

Wesnes KA, Edgar C, Tretter R, Bolodeoku J (2009). Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. Expert Opinion on Drug Safety 8: 1-12.

 

Wesnes KA, Garratt C, Wickens M, Gudgeon A, Oliver S (2000). Effects of sibutramine alone and with alcohol on cognitive function in healthy volunteers. British Journal of Clinical Pharmacology. 49: 110-117. 

 

Wesnes KA, Simpson PM, Christmas L, McClelland GR, Joiner IM (1989). Acute cognitive effects of moclobemide and trazodone, alone and in combination with alcohol, in the elderly. British Journal of Clinical Pharmacology. 27: 647-648. 

 

Wesnes KA, Simpson PM, Jansson B, Grahnen A, Weimann HJ, Kuppers H (1997). Moxonidine and cognitive function: interactions with moclobemide and lorazepam. European Journal of  Clinical Pharmacology. 52: 351-358. 

 

Williams SA, Wesnes KA, Oliver SD, Rapeport WG (1996). Absence of effect of sertraline on time-based sensitization of cognitive impairment with haloperidol. Journal of Clinical Psychiatry. 57: 7-11.

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