Microdose pharmacokinetics of IDX899 and IDX989, candidate HIV-1 non-nucleoside reverse transcriptase inhibitors, following oral and intravenous administration in healthy male subjects
ADULT;
AGED;
ARTICLE;
CLINICAL TRIAL;
CONTROLLED CLINICAL TRIAL;
CONTROLLED STUDY;
CROSSOVER PROCEDURE;
DIARRHEA;
DISTRIBUTION VOLUME;
DOSE RESPONSE;
DRUG ABSORPTION;
DRUG BIOAVAILABILITY;
DRUG BLOOD LEVEL;
DRUG CLEARANCE;
DRUG EXCRETION;
DRUG HALF LIFE;
DRUG INFUSION;
DRUG METABOLISM;
DRUG POTENCY;
DRUG SAFETY;
DRUG TRANSFORMATION;
DRUG URINE LEVEL;
HORDEOLUM;
HUMAN;
HUMAN EXPERIMENT;
HUMAN IMMUNODEFICIENCY VIRUS 1;
INFUSION SITE HEMATOMA;
INJECTION SITE REACTION;
MALE;
MASS SPECTROMETRY;
NONHUMAN;
NORMAL HUMAN;
OCULAR PRURITUS;
RADIOACTIVITY;
RANDOMIZED CONTROLLED TRIAL;
SINGLE DRUG DOSE;
SINUS CONGESTION;
VIRUS INHIBITION;
Washington, DC: Department of Health and Human Services; Accessed January 9, 2009
Panel on Antiretroviral Guidelines for Adults and Adolescents: Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington, DC: Department of Health and Human Services ; 2008. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed January 9, 2009.
IDX12899 and IDX12989, novel NNRTIs with potent anti-HIV activity, enhanced barrier to resistance and favorable pharmacokinetic profile
Richman DD, Dousson CB, Storer R., et al. IDX12899 and IDX12989, novel NNRTIs with potent anti-HIV activity, enhanced barrier to resistance and favorable pharmacokinetic profile. Paper presented at: 14th Conference on Retroviruses and Opportunistic Infections ; February 25-28, 2007 ; Los Angeles, Calif. Abstract 489.
In vitro cross-resistance profile for a next-generation NNRTI: IDX899
June 10-14 Sitges, Spain. Abstract
Jakubik JJ, Chapron C., Hubbard L., Seifer M., Standring DN In vitro cross-resistance profile for a next-generation NNRTI: IDX899. Paper presented at: XVII International HIV Drug Resistance Workshop: Basic Principles and Clinical Implications; June 10-14, 2008 ; Sitges, Spain. Abstract P-26.
US Food and Drug Administration Washington, DC, US Food and Drug Administration Accessed January 9, 2009
US Food and Drug Administration. Guidance for industry investigators, and reviewers: exploratory IND studies. Washington, DC, US Food and Drug Administration ; 2006. http://www.fda.gov/CDER/GUIDANCE/7086fnl.pdf. Accessed January 9, 2009.
Single-dose escalation and multiple-dose safety, tolerability, and pharmacokinetics of IDX899, a candidate human immunodeficiency virus type 1 nonnucleoside reverse transcriptase inhibitor, in healthy subjects
Zhou XJ, Pietropaolo K., Damphousse D., et al. Single-dose escalation and multiple-dose safety, tolerability, and pharmacokinetics of IDX899, a candidate human immunodeficiency virus type 1 nonnucleoside reverse transcriptase inhibitor, in healthy subjects. Antimicrobial Agents Chemother. 2009 ; 53: 1739-1746.
European Medicines Agency London, UK: European Medicines Agency Accessed January 9, 2009
European Medicines Agency. Position paper on non-clinical safety studies to support clinical trials with a single microdose. London, UK: European Medicines Agency ; 2004. http://www.emea.europa.eu/pdfs/human/swp/259902en.pdf. Accessed January 9, 2009.
US Food and Drug Administration Washington, DC, US Food and Drug Administration Accessed January 9, 2009
US Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. Washington, DC, US Food and Drug Administration ; 2004. http://www.fda.gov/oc/initiatives/criticalpath/ whitepaper.pdf. Accessed January 9, 2009.
Use of microdosing to predict pharmacokinetics at the therapeutic dose: Experience with 5 drugs
Lappin G., Kuhnz W., Jochemsen R., et al. Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clin Pharmacol Ther. 2006 ; 80: 203-215.
