Effects of SRX246 on an Experimental Model of Fear and Anxiety in Humans

NCT02922166 | Unknown Phase 1 DMC FDA Drug

• 2 other identifiers: AVN012T-M-1970
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effects of SRX246 on fear and anxiety based on fear-potentiated startle in humans. Additionally, the effects of the compound on emotion recognition will be explored.

Conditions

Fear; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in startle reflex between SRX246 and Placebo

  Subjects will be exposed to none (N), predictable (P) and unpredictable (U) acoustic and electric shocks.

  up to 7 days

Secondary Outcomes (2)

• Change in emotional expression recognition between SRX246 and Placebo

  up to 7 days

• Change in State Anxiety Scale between SRX246 and Placebo

  up to 7 days

Study Arms (2)

SRX246

EXPERIMENTAL

SRX246 oral dosage capsules, daily dose to be taken bid, for up to 7 days

Drug: SRX246

Placebo

PLACEBO COMPARATOR

Placebo oral dosage capsules, daily dose to be taken bid, for up to 7 days

Drug: Placebo

Interventions

SRX246 DRUG

oral capsule

SRX246

Placebo DRUG

oral capsule

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers, ages 21-50, inclusive.
• Subjects able to give their consent and have signed informed consent forms indicating that they understand the purpose and procedures of the study and are willing to participate in the study procedures and restrictions.
• Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of \>50kg (110 pounds).

You may not qualify if:

• Non-English speakers
• Current or history of Axis I psychiatric disorder(s) as identified with the Structured Clinical Interview for DSM-IV-TR, non-patient edition (SCID-np) and clinical evaluation.
• Active or history of active suicidal ideation.
• Lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV-TR, non-patient edition (SCID-np).
• All prescription and non-prescription medications and herbal remedies are prohibited within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication and until at least 7 days or 5 half-lives (whichever is longer) after last dose of study medication, except hormonal contraceptives in females.
• Clear evidence of a first-degree relative with history of psychosis, bipolar disorder or major depression as determined by the family history method; specifically, participant will know diagnosis or treatment in order to confirm presence of disorder.
• Subject is currently participating in another clinical trial in which (s)he is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month.
• Current evidence or history of significant medical illness or organic brain impairment, including syndrome of inappropriate antidiuretic hormone secretion (SIADH), diabetes insipidus (DI), stroke, epilepsy, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of SRX246, or influence psychophysiological responses.
• Current evidence of median nerve entrapment or carpal tunnel syndrome.
• Any laboratory abnormality that in the investigators' judgment is considered to be clinically significant (ECG, TSH, LFT, etc.).
• Abnormal urine specific gravity (below 1.00 or above 1.03) as documented by urine sample refractometry.
• Subject who has resting blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
• Subject who has resting pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart.
• Consumption of illicit substances or positive urine toxicology screen throughout the study.
• Pregnancy, lactating/breastfeeding, or positive pregnancy test.

Sponsors & Collaborators

• Azevan Pharmaceuticals: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

National Institute of Mental Health

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

SRX246

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 4, 2016
• Study Start: February 3, 2017
• Primary Completion: May 10, 2019
• Study Completion: December 1, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)