Healthy VolunteersPhase 1NCT03764449
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
A Phase 1 study testing Oral Balovaptan and IV Balovaptan in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Oral Balovaptan and IV Balovaptan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2019to 15 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
- Body Mass Index of 18 to 30 kg/m2, inclusive.
- For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
- For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.
Who cannot join
- Female subjects who are pregnant or lactating.
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Non-Randomized, Open-Label, Parallel Group, Two-Treatment Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.
- Conditions
- Healthy Volunteers
- Being tested
- Oral Balovaptan, IV Balovaptan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BalovaptanDrug
In Period 1, balovaptan was administered as a single oral dose.
In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.
IV BalovaptanDrug
In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.
In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. Receives: Drug: Oral Balovaptan; Drug: IV Balovaptan |
| Cohort 2 | Experimental | Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. Receives: Drug: Oral Balovaptan; Drug: IV Balovaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1)
Absolute oral bioavailability of a single dose A of balovaptan.
Measured: Day 1 of Period 1 (Period 1 is 14 days).
Secondary outcomes (41)
Absolute Bioavailability of Oral Balovaptan at Dose Level B (Cohort 2)
Absolute oral bioavailability of a single dose B balovaptan.
Measured: Day 1 of Period 1 (Period 1 is 14 days).
Absolute Bioavailability of Oral Balovaptan at Dose A and Dose B
Absolute oral bioavailability of balovaptan after once daily doses of Dose A and Dose B for 14 days.
Measured: Day 14 of Period 2 (Period 2 is 19 days).
Maximum Plasma Concentration (Cmax) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Time to Maximum Observed Plasma Concentration (Tmax) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Apparent Terminal Half-Life (t1/2) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Plasma Concentration Time Point (AUC0-last) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-inf of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days).
AUC0-inf of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days).
AUC0-inf of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days).
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-24) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Last Measurable Plasma Concentration (Clast) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Time of Last Measurable Plasma Concentration (Tlast) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Terminal Elimination Rate Constant (λz) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of Oral Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of M2 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of M3 Metabolites
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Total Body Clearance (CL) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Volume of Distribution (Vss) of IV Balovaptan
Measured: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Percentage of Participants With Treatment-Emergent Adverse Events
Measured: Up to 35 days from screening (sceening is up to 28 days prior to admission to the clinical research unit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start10 Jan 2019
- Primary completion4 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764449
- Sponsor's protocol ID
- WP40607
- Status last verified
- Feb 2020
- First submitted
- 30 Nov 2018
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.
PubMed 34176392
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Randomized, Open-Label, Parallel Group, Two-Treatment Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03764449
- Acronym / sponsor ID
- WP40607
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral Balovaptan, Drug: IV BalovaptanParticipants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. |
| Cohort 2 | Experimental | Drug: Oral Balovaptan, Drug: IV BalovaptanParticipants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
- Body Mass Index of 18 to 30 kg/m2, inclusive.
- For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
- For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.
Key exclusion criteria (2 listed)
- Female subjects who are pregnant or lactating.
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
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 |
|---|---|---|
| Oral BalovaptanIn Period 1, balovaptan was administered as a single oral dose. In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14. | Drug | Cohort 1, Cohort 2 |
| IV BalovaptanIn Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose. In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1)
Time frame: Day 1 of Period 1 (Period 1 is 14 days).
Absolute oral bioavailability of a single dose A of balovaptan.
41 secondary outcomes
Absolute Bioavailability of Oral Balovaptan at Dose Level B (Cohort 2)
Time frame: Day 1 of Period 1 (Period 1 is 14 days).
Absolute Bioavailability of Oral Balovaptan at Dose A and Dose B
Time frame: Day 14 of Period 2 (Period 2 is 19 days).
Maximum Plasma Concentration (Cmax) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Cmax of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Time to Maximum Observed Plasma Concentration (Tmax) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tmax of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Apparent Terminal Half-Life (t1/2) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
T1/2 of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Plasma Concentration Time Point (AUC0-last) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days)
AUC0-last of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-inf of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days).
AUC0-inf of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days).
AUC0-inf of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days).
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-24) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
AUC0-24 of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Last Measurable Plasma Concentration (Clast) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Clast of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Time of Last Measurable Plasma Concentration (Tlast) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Tlast of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Terminal Elimination Rate Constant (λz) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of Oral Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of M2 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
λz of M3 Metabolites
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Total Body Clearance (CL) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Volume of Distribution (Vss) of IV Balovaptan
Time frame: Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34176392Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 Oral Balovaptan and IV Balovaptan in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.
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 4 inclusion and 2 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 24 Feb 2020. 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 Netherlands. 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. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1) (time frame: Day 1 of Period 1 (Period 1 is 14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764449, which also lists 1 linked publication.
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 24 Feb 2020.