PMID- 27919901
OWN - NLM
STAT- MEDLINE
DCOM- 20171009
LR  - 20181113
IS  - 1098-6596 (Electronic)
IS  - 0066-4804 (Print)
IS  - 0066-4804 (Linking)
VI  - 61
IP  - 2
DP  - 2017 Feb
TI  - Safety and Pharmacokinetics of CD101 IV, a Novel Echinocandin, in Healthy Adults.
LID - 10.1128/AAC.01627-16 [doi]
LID - e01627-16
AB  - CD101 IV is a novel echinocandin with distinctive pharmacokinetic properties that 
      is being developed as a once-weekly treatment for candidemia and invasive 
      candidiasis. CD101 has potent in vitro activity and in vivo efficacy against a 
      broad range of Candida and Aspergillus species. The primary objective of two 
      randomized, double-blind, placebo-controlled, dose-escalation studies in healthy 
      adults was to determine the safety and tolerability of CD101 IV. Sequential 
      cohorts of 8 subjects (n = 6, active; n = 2, placebo) were administered single 
      (50, 100, 200, 400 mg) or multiple once-weekly (100 mg given once weekly for two 
      weeks [x2], 200 mg x2, 400 mg x3) doses of CD101 IV infused over 1 h. There were 
      no deaths, serious adverse events (SAEs), severe adverse events (AEs), or 
      withdrawals from the study due to an AE. The majority of AEs were mild, and all 
      completely resolved. There was a higher incidence of total AEs and mild transient 
      infusion reactions in the 400-mg x3 dose group. There were no clinically 
      meaningful trends in postbaseline laboratory abnormalities and no safety issues 
      related to electrocardiograms, vital signs, or physical exams. CD101 showed 
      dose-proportional plasma exposures, minor accumulation (30% to 55%), low apparent 
      clearance (<0.28 liter/h), long half-life (t(1/2)) (>80 h), and minimal urine 
      excretion. CD101 IV was safe and well tolerated at single and multiple doses of 
      up to 400 mg given once weekly for 3 weeks and exhibited a long t(1/2), minimal 
      accumulation over several weeks, negligible renal excretion, and high plasma 
      exposures enabling once-weekly dosing.
CI  - Copyright (c) 2017 Sandison et al.
FAU - Sandison, Taylor
AU  - Sandison T
AD  - Cidara Therapeutics, Inc., San Diego, California, USA tsandison@cidara.com.
FAU - Ong, Voon
AU  - Ong V
AD  - Cidara Therapeutics, Inc., San Diego, California, USA.
FAU - Lee, Jonathan
AU  - Lee J
AD  - Cidara Therapeutics, Inc., San Diego, California, USA.
FAU - Thye, Dirk
AU  - Thye D
AD  - Cidara Therapeutics, Inc., San Diego, California, USA.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170124
PL  - United States
TA  - Antimicrob Agents Chemother
JT  - Antimicrobial agents and chemotherapy
JID - 0315061
RN  - 0 (Echinocandins)
RN  - 0 (echinocandin CD101 IV)
SB  - IM
MH  - Adult
MH  - Drug Administration Schedule
MH  - Echinocandins/*administration & dosage/adverse effects/*pharmacokinetics
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Middle Aged
PMC - PMC5278714
OTO - NOTNLM
OT  - CD101
OT  - Candida
OT  - antifungal agents
OT  - clinical trials
OT  - echinocandin
OT  - pharmacokinetics
EDAT- 2016/12/07 06:00
MHDA- 2017/10/11 06:00
PMCR- 2017/01/24
CRDT- 2016/12/07 06:00
PHST- 2016/07/29 00:00 [received]
PHST- 2016/11/29 00:00 [accepted]
PHST- 2016/12/07 06:00 [pubmed]
PHST- 2017/10/11 06:00 [medline]
PHST- 2016/12/07 06:00 [entrez]
PHST- 2017/01/24 00:00 [pmc-release]
AID - AAC.01627-16 [pii]
AID - 01627-16 [pii]
AID - 10.1128/AAC.01627-16 [doi]
PST - epublish
SO  - Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01627-16. doi: 
      10.1128/AAC.01627-16. Print 2017 Feb.