NCT03764449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 30, 2018

Results QC Date

February 10, 2020

Last Update Submit

February 10, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1)

    Absolute oral bioavailability of a single dose A of balovaptan.

    Day 1 of Period 1 (Period 1 is 14 days).

Secondary Outcomes (41)

  • Absolute Bioavailability of Oral Balovaptan at Dose Level B (Cohort 2)

    Day 1 of Period 1 (Period 1 is 14 days).

  • Absolute Bioavailability of Oral Balovaptan at Dose A and Dose B

    Day 14 of Period 2 (Period 2 is 19 days).

  • Maximum Plasma Concentration (Cmax) of IV Balovaptan

    Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  • Cmax of Oral Balovaptan

    Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  • Cmax of M2 Metabolites

    Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).

  • +36 more secondary outcomes

Study Arms (2)

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.

Drug: Oral BalovaptanDrug: 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.

Drug: Oral BalovaptanDrug: IV Balovaptan

Interventions

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.

Cohort 1Cohort 2
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.

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pra International Group B.V

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34176392DERIVED

MeSH Terms

Interventions

balovaptan

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 5, 2018

Study Start

January 10, 2019

Primary Completion

March 4, 2019

Study Completion

March 15, 2019

Last Updated

February 24, 2020

Results First Posted

February 24, 2020

Record last verified: 2020-02

Locations

NL(1)