A Phase 1, Randomized, Double-blind, Placebo-controlled Crossover Study of RG7314 on the Potential Regulation of Higher Brain Functions in Healthy Male Participants: Proof of Mechanism

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RG7314 RD + AVP SD

Drug: Placebo RD + AVP SD

Drug: Placebo RD + Placebo SD

Study type

Interventional

Funder types

Industry

Identifiers

NCT02205073

2014-000867-42 (EudraCT Number)

BP29412

Details and patient eligibility

About

This is a single site, randomized, double-blind, three period cross-over, placebo-controlled, proof of mechanism study in healthy male subjects. The study will investigate whether the directionality of brain activity and connectivity in response to intranasal vasopressin treatment is similar to earlier studies and explores the effect of short-term treatment with RG7314 on functional MRI as a pharmacodynamic marker. While in the scanner, the participants will be asked to perform a face matching task and a Theory of Mind task, among other assessments. Participants' exposure to study drug will be assessed and all participants will receive follow-up examination 1 and 4 weeks after last dose.

Enrollment

32 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Right-handed, healthy non-smoker male adults, 18 to 45 years of age
A body mass index between 18 to 32 kg/m2 inclusive and total weight in the range of 50-100 kg
Participants and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose
In the investigator's opinion, the subject is deemed appropriate for participation in the study, capable of following the study schedule of assessments and complying with the study restrictions and discontinuation of prohibited medication will not pose undue risks to the participants

Exclusion criteria

History of alcohol and/or substance abuse/dependence
History of relapsing or current psychiatric or neurological disorders
Participants who, in the Investigator's judgment, pose a suicidal risk, or any subject with a history of suicidal attempts or behavior
Positive results for serology test for HIV, Hepatitis B, hepatitis C viruses
Confirmed (e.g. 2 consecutive measurements) clinically significant abnormality on 12-lead electrocardiogram (ECG), including a QTcF of >/= 450 milliseconds
Confirmed clinically significant abnormality in vital signs, clinical chemistry and/or urinalysis
Active stomach ulcer disease or active gastrointestinal bleeding
Personal or family history (first or second degree relatives) of cerebral aneurysm
Personal history of stroke or traumatic head injury
Confirmed clinically significant abnormality in parameters of hematology or coagulation
History of coagulopathies, bleeding disorders or blood dyscrasias
History of hematological malignancy or myelosuppression (including iatrogenic).
Contraindications for MRI scans or any brain/head abnormalities restricting MRI eligibility
Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
Use of prohibited medications within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
Participation in an investigational drug study within 90 days prior to randomization
Donation or loss of blood over 500 mL within three months prior to randomization
Chronic rhinitis, allergic rhinitis, nasal polyps or any other nasal pathology that may affect the absorption of intranasal AVP according to investigator judgment
Concomitant disease, condition or treatment which might interfere with the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Unwilling or unable to comply with the following lifestyle guidelines: (1) participants will abstain from alcohol for the entire study participation; (2) abstinence from any psychoactive agents or drugs of abuse for the duration of the study period; (3) participants should abstain from unusual strenuous exercise throughout the entire study.