A Phase 1 interventional study of VA106483 and Placebo in Nocturia, sponsored by Vantia Ltd. Completed at 1 site in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-01.
Sponsored by Vantia Ltd · Phase 1, Interventional, and Treatment
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.
Nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). The most common causes are detrusor over-activity, reduced nighttime functional bladder capacity, and nocturnal polyuria.
VA106483 is a selective vasopressin V2-receptor agonist in development for nocturia. VA106483 is a non-peptide drug that displays much improved oral availability over desmopressin and low dependence on glomerular filtration for its elimination.
VA106483 has been administered to 184 subjects (including healthy adult subjects [males and females], children [males and females] with nocturia and 48 elderly males [aged 65 years and over]). It has been administered as single doses both intravenously, up to doses of approximately 250 mg and orally up to 50 mg It is also being investigated in approximately 123 male subjects (two-thirds on active medication, one third on placebo) with nocturia in a current study with dosing for up to 8 weeks.
This intra-subject dose escalation study has previously been conducted in 10 elderly male subjects to determine whether subjects demonstrated a dose-dependent pharmacokinetic and pharmacodynamic (urine osmolality and diuresis) response and whether the dose of VA106483 could be titrated within an individual patient to achieve optimal clinical response in clinical practice. Given that to date, only 8 females have been exposed to VA106483, the purpose of this study is to confirm that the described duration of pharmacokinetics and pharmacodynamics of VA106483 in males is similar in females.
124 studies on the registry are indexed under Nocturia; 24 are open to participants now.
This study's enrollment of 21 is below the median of 67 across 94 interventional studies indexed under Nocturia.
Browse Nocturia studies →Vantia Ltd is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: VA106483
Drug: VA106483
Drug: VA106483
Other: Placebo
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Placebo on Day 1
Pharmacokinetics
VA106483 plasma concentration pre-dose over a 24hr post-dose period to assess pharmacokinetics of each dose level
Time frame: 10 days
Pharmacodynamics
Urine volume and osmolality
Time frame: 10 days
Safety and Tolerability
AEs, laboratory safety tests, vital signs and ECG, physical examination.
Time frame: 10 days
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Vantia Ltd