A Study to Evaluate the Safety of the Coadministration of... | NCT03203499

Studies
A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol

NCT03203499

Sponsor

Amygdala Neurosciences, Inc.

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ANS-6637 Oral Tablet
Placebo Oral Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2017Actual

Primary Completion Date

Nov 15, 2017Actual

Completion Date

Nov 15, 2017Actual

First Submitted Date

Jun 28, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2018

Last Update Posted Date

Jan 17, 2018Actual

Description Module

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ANS-6637	Experimental	Single ascending doses of ANS-6637 administered orally	Drug: ANS-6637 Oral Tablet
Placebo	Placebo Comparator	Placebo administered orally	Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANS-6637 Oral Tablet	Drug	Ascending single doses administered orally.	ANS-6637

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of adverse events		Up to 36 hours postdose

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed serum concentration (Cmax)		Up to 48 hours postdose
Time to maximum observed serum concentration (Tmax)		Up to 48 hours postdose
Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male adults, between 21 and 45 years of age, inclusive.
Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening).
Resting semisupine vital signs at screening and each clinic admission within the following ranges:
1. Systolic blood pressure 90 to 140 mmHg
2. Diastolic blood pressure of 50 to 90 mmHg
3. Heart rate of 40 to 90 beats per minute (bpm)
Current alcohol users who are self-reported moderate drinkers, defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least 1 occasion in the 30 days prior to screening. One standard alcoholic drink (14 grams of EtOH) is equivalent to 43 mL (1.5 oz) hard liquor, 142 mL (5 oz) wine or 341 mL (12 oz) beer.

Exclusion Criteria:

Drug or alcohol dependence within the 12 months prior to screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
Current or prior diagnosis of any condition where alcohol consumption is contraindicated, including, but not limited to, hypertriglyceridemia, pancreatitis, liver disease, porphyria, and/or congestive heart failure, that is clinically relevant, as judged by the investigator or designee.
Positive urine drug test for EtOH, cocaine, oxycodone and other opioids, amphetamines, benzodiazepines and/or cannabinoids at clinic admission. Positive results may be repeated and/or subjects rescheduled at the investigator's or designee's discretion.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Healthy male moderate drinkers.

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders