The minimal impact of food on the pharmacokinetics of ridaforolimus

Cancer Chemotherapy and Pharmacology

Volumn 70, Issue 1, 2012, Pages 177-182

  Stroh, Mark ^a   Li, Xiaodong ^a   Marsilio, Sabrina ^a   Panebianco, Deborah ^a   Johnson Levonas, Amy ^a   Juan, Axel ^b   Orford, Keith ^a   Agrawal, Nancy ^a   Trucksis, Michele ^a   Wagner, John A ^a   Murphy, Gail ^a   Iwamoto, Marian ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b SeaView Research Inc   (United States)

Author keywords

Food effect; Pharmacokinetics; Ridaforolimus

Indexed keywords

RIDAFOROLIMUS;

ACNE; ADULT; ADVERSE OUTCOME; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FOOD; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SKIN ABSCESS; STOMATITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TONSILLITIS; TOOTH PAIN;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DIETARY FATS; FASTING; FOOD-DRUG INTERACTIONS; HUMANS; MALE; METABOLIC CLEARANCE RATE; SIROLIMUS; STOMATITIS; TIME FACTORS; TONSILLITIS; YOUNG ADULT;

EID: 84863445040     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-012-1897-8     Document Type: Article

References (17)

1. Hartford CM, Desai AA, Janisch L, Karrison T, Rivera VM, Berk L, Loewy JW, Kindler H, Stadler WM, Knowles HL, Bedrosian C, Ratain MJ (2009) A Phase I Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Deforolimus in Patients with Advanced Malignancies. Clin Cancer Res 15:1428-1434
2. Mita M, Sankhala K, Abdel-Karim I, Mita A, Giles F (2008) Deforolimus (AP23573) a novel mTOR inhibitor in clinical development. Exp Opin Invest Drugs 17:1947-1954
3. Rapamune (sirolimus) oral solution and tablets [package insert] (2010). New York, NY, Pfizer, Inc
4. Afinitor [package insert] (2009). East Hanover, NJ, Novartis
5. Torisel (temisirolimus concentrate for injection) [prescribing information] (2010). New York, NY, Pfizer
6. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ (2007) Temsirolimus, inter feron alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281 (Pubitemid 46849157)
7. FDA/CDER Regulatory Guidance Page (2011) Guidance for industry: food-effect bioavailablity and fed bioequivalence studies. http://www.fda.gov/ cder/guidance/5194fnl.htm. 25 Oct 2011
8. Halfdanarson TR, Jatoi A (2010) Oral cancer chemotherapy: the critical interplay between patient education and patient safety. Curr Oncol Rep 12:247-252
9. DeMario MD, Ratain MJ (1998) Oral chemotherapy: rationale and future directions. J Clin Oncol 16:2557-2567 (Pubitemid 28309055)
10. Hartford CM, Ratain MJ (2007) Rapamycin: something old, something new, sometimes borrowed and now renewed. Clin Pharmacol Ther 82:381-388 (Pubitemid 47414349)
11. Laplanche R, Meno-Tetang GML, Kawai R (2007) Physiologically based pharmacokinetic (PBPK) modeling of everolimus (RAD001) in rats involving non-linear tissue uptake. J Pharmacokinet Pharmacodyn 34:373-400 (Pubitemid 46873032)
12. Minematsu T, Sugiyama E, Kusama M, Hori S, Yamada Y, Ohtani H, Sawada Y, Sato H, Takayama T, Sugawara Y, Makuuchi M, Iga T (2004) Effect of hematocrit on pharmacokinetics of tacrolimus in adult living donor liver transplant recipients. Transplant Proc 36:1506-1511 (Pubitemid 38903017)
13. Mita MM, Mita AC, Chu QS, Rowinsky EK, Fetterly GJ, Goldston M, Patnaik A, Mathews L, Ricart AD, Mays T, Knowles H, Rivera VM, Kreisberg J, Bedrosian CL, Tolcher AW (2008) Phase I trial of the novel mammalian target of rapamycin inhibitor deforolimus (AP23573; MK-8669) administered intravenously daily for 5 days every 2 weeks to patients with advanced malignancies. J Clin Oncol 26:361-367 (Pubitemid 351171685)
14. Fetterly GJ, Mita MM, Britten CD, Poplin E, Tap WD, Carmona A, Yonemoto L, Bedrosian CL, Rubin EH, Tolcher AW (2008) Pharmacokinetics of oral deforolimus (AP23573, MK-8669) [Abstract 14555]. ASCO Ann Meet 26(15S)
15. Lentz KA (2008) Current methods for predicting human food effect. AAPS J 10:282-288
16. Gu CH, Li H, Levons J, Lentz K, Gandhi RB, Raghavan K, Smith RL (2007) Predicting effect of food on extent of drug absorption based on physicochemical properties. Pharm Res 24:1118-1130 (Pubitemid 46798891)
17. Mita MM, Britten CD, Poplin E, Tap WD, Carmona A, Yonemoto L, Wages DS, Bedrosian CL, Rubin EH, Tolcher AW (2008) Deforolimus trial 106-A Phase l trial evaluating 7 regimens of oral deforolimus (AP23573, MK-8669). ASCO Meet Abstr 26(Suppl):3509