Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

Vantia

Status and phase: Completed; Phase 1

Conditions: Benign Prostatic Hypertrophy (BPH); Nocturia

Treatments: Drug: VA106483

Study type: Interventional

Funder types: Industry

Identifiers

NCT01330927

483-008

Details and patient eligibility

About

The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.

Full description

VA106483 is a selective vasopressin V2-receptor (V2-receptor) agonist that is being developed for the treatment of nocturia.

The antidiuretic effect of V2-receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and nocturia.

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). It is the most bothersome symptom of benign prostatic hypertrophy and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (nocturnal polyuria).

Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists.

The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.

Enrollment: 30 patients

Sex: Male

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)

Exclusion criteria

• Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
• Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
• Other protocol defined eligibility criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 5 patient groups, including a placebo group

VA106483 0.5 mg

Experimental group

Treatment:

Drug: VA106483

VA106483 1 mg

Experimental group

Treatment:

Drug: VA106483

VA106483 2 mg

Experimental group

Treatment:

Drug: VA106483

VA106483 4 mg

Experimental group

Treatment:

Drug: VA106483

Sugar pill

Placebo Comparator group

Treatment:

Drug: VA106483