NocturiaPhase 1NCT01171391
VA106483 Dose Response in Females
A Phase 1 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 1 site in United States.
Trial summary
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- VA106483
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects 40 years and above
- BMI 18 to 32 kg/m2
- Using adequate contraception and providing negative pregnancy tests pre-dose
- In good health as determined by medical history and screening tests
- Subject is willing and able to abstain from alcohol and caffeine-containing food and beverages 72 hours prior to dosing and throughout the study
- Provide written, informed consent
Who cannot join
- Pregnancy or lactation
- Evidence of serious pathology or diseases including heart, hormone, liver and kidney, psychiatric and neurological problems, including syndrome of inappropriate antidiuretic hormone secretion, polydipsia or diabetes insipidus
- Likely to be hypersensitive to VA106483
- History of any relevant allergy
- Participation in a clinical study within 30 days
- Donation of blood (500 mL) within 60 days prior to dosing
Show all 13Show fewer
- A history of alcohol abuse or drug addiction
- Positive results for HIV, HBV or HCV or drugs of abuse
- Currently taking any diuretics or clinically significant cytochrome 3A4 inhibitors or inducers
- Use of any non-prescription preparation within 72 hours prior to dosing, with the exception of ibuprofen, and acetaminophen used at recommended doses
- Treatment within the previous 3 months of drugs known to have a well defined potential for hepatoxicity
- Current smokers or recent ex-smokers
- Other protocol defined eligibility criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services
Overland Park, Kansas, 66211
About this study
Official title: An Open Label, Dose Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Female Subjects
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.
Read the detailed description
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.
- Conditions
- Nocturia
- Being tested
- VA106483, Placebo
- Keywords
- Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Females
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA106483Drug
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
PlaceboOther
Placebo on Day 1
| Study group | Role | What they receive |
|---|---|---|
| VA106483 1mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 2mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 4mg | Experimental | Not described Receives: Drug: VA106483 |
| Sugar pill | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
VA106483 plasma concentration pre-dose over a 24hr post-dose period to assess pharmacokinetics of each dose level
Measured: 10 days
Secondary outcomes (2)
Pharmacodynamics
Urine volume and osmolality
Measured: 10 days
Safety and Tolerability
AEs, laboratory safety tests, vital signs and ECG, physical examination.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph Schutz, Principal investigator, Quintiles Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171391
- Sponsor's protocol ID
- 483-007
- Status last verified
- Nov 2010
- First submitted
- 19 Jul 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Female Subjects
- ClinicalTrials.gov ID
- NCT01171391
- Acronym / sponsor ID
- 483-007
- Conditions
- Nocturia
- Keywords
- Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Females
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VA106483 1mg | Experimental | Drug: VA106483 |
| VA106483 2mg | Experimental | Drug: VA106483 |
| VA106483 4mg | Experimental | Drug: VA106483 |
| Sugar pill | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female subjects 40 years and above
- BMI 18 to 32 kg/m2
- Using adequate contraception and providing negative pregnancy tests pre-dose
- In good health as determined by medical history and screening tests
- Subject is willing and able to abstain from alcohol and caffeine-containing food and beverages 72 hours prior to dosing and throughout the study
Key exclusion criteria (13 listed)
- Pregnancy or lactation
- Evidence of serious pathology or diseases including heart, hormone, liver and kidney, psychiatric and neurological problems, including syndrome of inappropriate antidiuretic hormone secretion, polydipsia or diabetes insipidus
- Likely to be hypersensitive to VA106483
- History of any relevant allergy
- Participation in a clinical study within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA1064831 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7 | Drug | VA106483 1mg, VA106483 2mg, VA106483 4mg |
| PlaceboPlacebo on Day 1 | Other | Sugar pill |
Primary outcome
Pharmacokinetics
Time frame: 10 days
VA106483 plasma concentration pre-dose over a 24hr post-dose period to assess pharmacokinetics of each dose level
2 secondary outcomes
Pharmacodynamics
Time frame: 10 days
Safety and Tolerability
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Schutz principal investigator
Quintiles Phase I Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.