A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation, Single Dose, and Steady-State Pharmacokinetic Study of 9cUAB30 in Healthy Volunteers.
Adolescent
Adult
Aged
Area Under Curve
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Fatty Acids, Unsaturated
/ administration & dosage
Female
Healthy Volunteers
Humans
Male
Middle Aged
Naphthalenes
/ administration & dosage
Neoplasms
/ prevention & control
Placebos
/ administration & dosage
Retinoids
/ administration & dosage
Young Adult
Journal
Cancer prevention research (Philadelphia, Pa.)
ISSN: 1940-6215
Titre abrégé: Cancer Prev Res (Phila)
Pays: United States
ID NLM: 101479409
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
18
06
2019
revised:
04
08
2019
accepted:
28
08
2019
pubmed:
6
9
2019
medline:
22
9
2020
entrez:
6
9
2019
Statut:
ppublish
Résumé
9cUAB30 is a synthetic analogue of 9-cis retinoic acid with chemoprevention activity in cell lines and animal models. The purpose of this phase I placebo-controlled, double-blinded, dose escalation study of 9cUAB30 was to evaluate its safety, pharmacokinetics, and determine a dose for future phase II studies. Participants received a single dose of study drug (placebo or 9cUAB30) on day 1 followed by a 6-day drug-free period and then 28 days of continuous daily dosing starting on day 8. Fifty-three healthy volunteers were enrolled into five dose cohorts (20, 40, 80, 160, and 240 mg). Participants were randomized within each dose level to receive either 9cUAB30 (
Identifiants
pubmed: 31484659
pii: 1940-6207.CAPR-19-0310
doi: 10.1158/1940-6207.CAPR-19-0310
pmc: PMC7008944
mid: NIHMS1539044
doi:
Substances chimiques
Fatty Acids, Unsaturated
0
Naphthalenes
0
Placebos
0
Retinoids
0
UAB 30
PFP09575EX
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
903-912Subventions
Organisme : NCI NIH HHS
ID : N01CN35153
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000427
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA014520
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK079626
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002373
Pays : United States
Informations de copyright
©2019 American Association for Cancer Research.
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