Pupillography as a sensitive, noninvasive biomarker in healthy volunteers: First-in-man study of BAY 63-9044, a new 5-HT1A-receptor agonist with dopamine agonistic properties

European Journal of Clinical Pharmacology

Volumn 63, Issue 12, 2007, Pages 1123-1128

  Wensing, Georg ^a   Haase, Claus ^b   Brendel, Erich ^a   Böttcher, Michael Friedrich ^a  

^a BAYER PHARMA AG   (Germany)

^b Knappschaft Hospital   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; BAY 639044; BIOLOGICAL MARKER; CORTICOTROPIN; DOPAMINE RECEPTOR STIMULATING AGENT; HYDROCORTISONE; PLACEBO; PROLACTIN; SEROTONIN 1A AGONIST; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BODY TEMPERATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DRUG DETERMINATION; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; ELECTROENCEPHALOGRAPHY; FOLLOW UP; HUMAN; LIGATION; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PRIORITY JOURNAL; PUPIL; PUPIL REFLEX; PUPILLOGRAPHY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; VOMITING;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; BIOLOGICAL MARKERS; DOPAMINE AGONISTS; DOSE-RESPONSE RELATIONSHIP, DRUG; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; PUPIL; SEROTONIN AGONISTS; THIAZOLES;

EID: 36148999381     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-007-0372-7     Document Type: Article

References (18)

1. Parent A, Cote DJ, Lavoie B (1995) Chemical anatomy of primate basal ganglia. Prog Neurobiol 46:131-197
2. DeDeurwaerdere P, Spampinato U (2001) The nigrostriatal dopamine system: a neglected target for 5-HT2C receptors. Trends Pharmacol Sci 22:502-504
3. Mauler F, Fahrig F, Horvath E, Jork R (2001) Inhibition of the provoked glutamate release by the neuroprotective 5-HT (1A) receptor agonist BAY x 3702 in vitro and in vivo. Brain Res 888:150-157
4. Ohman J, Braakman R, Legout V (2001) Repinotan (BAY x 3702): a 5-HT1A agonist in traumatically brain injured patients. J Neurotrauma 18:1313-1321
5. Stanford IM, Kantaria MA, Chahal HS, Louci f KC, Wilson CL (2005) 5-Hydroxytryptamine induced excitation and inhibition in the subthalamic nucleus: action of 5-HT(2C), 5-HT(4), and 5-HT(1A) receptors. Neuropharmacology 49:1228-1234
6. 1A receptor agonist-mediated protection from MPTP toxicity in mouse and macaque models of Parkinson's disease. Neurobiol Dis 23:77-86
7. Böttcher M (1999) Pupillography in clinical pharmacology. In: Kuhlmann J, Böttcher M (eds) Pupillography: principles, methods and applications. W. Zuckschwerdt Verlag, Clinical Pharmacology 18:13-26
8. A compounds. Basic Pharmacology and Toxicology 96:246
9. Kuhlmann J, Wensing G (2006) The application of biomarkers in early drug development. Current Clinical Pharmacology 1:185-191
10. Rolan P (1997) The contribution of clinical pharmacology surrogates and models to drug development - a critical appraisal. Br J Clin Pharmacol 44:219-225
11. Rolan P, Atkinson AJ, Lesko LJ (2003) Use of biomarkers from drug discover through clinical practice: report of the ninth European federation of pharmaceutical sciences conference on optimizing drug development. Clin Pharmacol Ther 73:284-291
12. Atkinson J, Magnuson WG, Colburn WA et al (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69:89-95
13. Danhof M, Alvan G, Dahl SG, Kuhlmann J, Paintaud G (2005) Mechanism-based pharmacokinetic - pharmacodynamic modeling - a new classification of biomarkers. Pharm Res 22:1432-1437
14. Fanciullacci M, Sicuteri R, Allessandri M, Geppetti P (1995) Buspirone, but not sumatriptan, induces miosis in humans: relevance for a serotonergic pupil control. Clin Pharmacol Ther 57:349-355
15. Phillips MA, Szabadi E, Bradshaw CM (1999) The effects of the novel anxiolytic drug lesopitron, a full and selective 5-HT1A receptor agonist, on pupil diameter and oral temperature in man: comparison with buspirone. J Pschopharmacol 13(4):391-397
16. Samuels ER, Hou RH, Langley RW, Szabadi E, Bradshaw CM (2006) Comparison of pramipexole and modafinil arousal, autonomic, and endocrine functions in healthy subjects. J Psychopharmacol 20(6):756-770
17. Sibille M, Deigat N, Kirkesseli S, VitalDurand D (1998) Adverse events in phase I studies: a report in 1015 healthy volunteers. Eur J Clin Pharmacol 54:13-20
18. Lutfullin A, Kuhlmann J, Wensing G (2005) Adverse events in volunteers participating in phase I clinical trials: a single center five-year survey in 1559 subjects. Int J Clin Pharmacol Ther 43:217-226