PMID- 24374821
OWN - NLM
STAT- MEDLINE
DCOM- 20141229
LR  - 20140506
IS  - 1552-4604 (Electronic)
IS  - 0091-2700 (Linking)
VI  - 54
IP  - 6
DP  - 2014 Jun
TI  - Randomized, placebo-controlled single-ascending-dose study to evaluate the 
      safety, tolerability and pharmacokinetics of the HIV nucleoside reverse 
      transcriptase inhibitor, BMS-986001, in healthy subjects.
PG  - 657-64
LID - 10.1002/jcph.252 [doi]
AB  - The objectives of this study were to evaluate the safety, tolerability and 
      pharmacokinetics (PK) of BMS-986001 as a single oral dose in healthy male 
      subjects. Sixty-four healthy male subjects were randomized to receive a single 
      dose of BMS-986001 or placebo in this single-blind, placebo-controlled, 
      sequential ascending-dose study. There were eight treatment groups (10, 30, 100, 
      300, 600, and 900 mg fed; and 100 and 300 mg fasted) of eight subjects each 
      (BMS-986001 n = 6/placebo n = 2). BMS-986001 was well tolerated, with no serious 
      adverse events (AEs), deaths, or discontinuations due to AEs reported. AEs were 
      experienced by 14.6% of subjects receiving BMS-986001; however, these did not 
      appear to be dose related and were not considered to be related to study drug. 
      BMS-986001 was rapidly absorbed and exhibited a linear dose-exposure relationship 
      across the dose range studied. PK appeared similar whether administered with or 
      without food. Administration of BMS-986001 as a single dose was generally safe 
      and well tolerated. A linear dose-exposure relationship was seen across all doses 
      studied, with no apparent food effect. Further clinical development is warranted.
CI  - (c) 2014, The American College of Clinical Pharmacology.
FAU - Urata, Y
AU  - Urata Y
AD  - Oncolys BioPharma, Tokyo, Japan.
FAU - Paintsil, E
AU  - Paintsil E
FAU - Cheng, Y-C
AU  - Cheng YC
FAU - Matsuda, T
AU  - Matsuda T
FAU - Sevinsky, H
AU  - Sevinsky H
FAU - Hawthorne, D
AU  - Hawthorne D
FAU - Bertz, R
AU  - Bertz R
FAU - Hanna, G J
AU  - Hanna GJ
FAU - Grasela, D
AU  - Grasela D
FAU - Hwang, C
AU  - Hwang C
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140117
PL  - England
TA  - J Clin Pharmacol
JT  - Journal of clinical pharmacology
JID - 0366372
RN  - 0 (Anti-HIV Agents)
RN  - 0 (BMS-986001)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - VC2W18DGKR (Thymidine)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/adverse effects/blood/*pharmacokinetics/urine
MH  - Dose-Response Relationship, Drug
MH  - Fasting/metabolism
MH  - *Food-Drug Interactions
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Reverse Transcriptase Inhibitors/adverse effects/blood/*pharmacokinetics/urine
MH  - Single-Blind Method
MH  - Thymidine/adverse effects/*analogs & derivatives/blood/pharmacokinetics/urine
MH  - Young Adult
OTO - NOTNLM
OT  - BMS-986001
OT  - human immunodeficiency virus type 1
OT  - nucleoside reverse transcriptase inhibitor
OT  - pharmacokinetics
OT  - safety
EDAT- 2014/01/01 06:00
MHDA- 2014/12/30 06:00
CRDT- 2013/12/31 06:00
PHST- 2013/10/14 00:00 [received]
PHST- 2013/12/18 00:00 [accepted]
PHST- 2013/12/31 06:00 [entrez]
PHST- 2014/01/01 06:00 [pubmed]
PHST- 2014/12/30 06:00 [medline]
AID - 10.1002/jcph.252 [doi]
PST - ppublish
SO  - J Clin Pharmacol. 2014 Jun;54(6):657-64. doi: 10.1002/jcph.252. Epub 2014 Jan 17.