90606
document
Lack of effect of food on the steady state pharmacokinetics of BMS-181101 , an antidepressant , in healthy subjects . The effect of food on the pharmacokinetics of BMS-181101 , a new anti-depressant under development , was investigated in 12 healthy male volunteers at steady state . Each subject received a 15 mg oral dose of BMS-181101 twice a day ( q 12 h ) for 11 days and a morning dose of BMS-181101 on day 12 . Six subjects were randomly assigned to receive BMS-181101 under fasted conditions from days 1 to 6 and then crossed over to fed conditions from days 7 to 12 . The other six subjects received the reverse conditions , fed for days 1-6 and fasted for days 7-12 . Serial blood samples were collected up to 12 h on days 6 and 12 following the administration of the morning dose . In addition , trough blood samples were collected on days 4 , 5 , 10 , and 11 prior to the morning dose . Plasma samples were analyzed for intact BMS-181101 using a validated high-performance liquid chromatography method with an electrochemical detector . BMS-181101 was well tolerated both with and without ingestion of food . The statistical evaluation of the Cmin values indicated that steady state of BMS-181101 was achieved by the fourth day of dosing regardless of whether the subject was fasted or fed . When BMS-181101 was administered with food , Cmax was reduced by about 25 % and tmax was prolonged by 1 h. However , AUCtau , t1/2 , and time to attain steady state of BMS-181101 were not altered by ingestion of food . In summary , BMS-181101 can be given with food without adversely impacting the safety or pharmacokinetic profiles of the drug .
90607
Intervention_Pharmacological
food
90608
Intervention_Pharmacological
BMS-181101
90609
Intervention_Pharmacological
BMS-181101
90610
Intervention_Pharmacological
BMS-181101
90611
Intervention_Pharmacological
BMS-181101
90612
Intervention_Pharmacological
BMS-181101
90613
Intervention_Pharmacological
BMS-181101
90614
Intervention_Pharmacological
BMS-181101
90615
Outcome_Physical
steady state pharmacokinetics of BMS-181101
90616
Outcome_Physical
effect of food on the pharmacokinetics of BMS-181101
90617
Outcome_Physical
Serial blood samples
90618
Outcome_Physical
trough blood samples
90619
Outcome_Physical
Plasma samples
90620
Outcome_Physical
intact BMS-181101
90621
Outcome_Other
tolerated
90622
Outcome_Other
Cmin values
90623
Outcome_Other
steady state
90624
Outcome_Other
Cmax
90625
Outcome_Physical
was reduced
90626
Outcome_Other
tmax
90627
Outcome_Physical
was prolonged
90628
Outcome_Other
AUCtau
90629
Outcome_Physical
,
90630
Outcome_Other
t1/2
90631
Outcome_Physical
, and
90632
Outcome_Other
time to attain steady state
90633
Outcome_Physical
of BMS-181101
90634
Outcome_Other
safety
90635
Outcome_Physical
pharmacokinetic profiles
90636
Participant_Condition
healthy
90637
Participant_Sample-size
12
90638
Participant_Condition
healthy
90639
Participant_Sex
male
90640
Participant_Sample-size
Six