## Protocol Section
### Identification Module
**NCT ID:** NCT02224079

**Brief Title:** Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers

**Official Title:** Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.

#### Organization Study ID Info
**ID:** 1180.3
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-08-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-08-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2002-06

**Type:** ACTUAL

#### Start Date
**Date:** 2002-04

**Status Verified Date:** 2014-08

#### Study First Post Date
**Date:** 2014-08-25
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-21
**Study First Submit QC Date:** 2014-08-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boehringer Ingelheim

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BIIB 722 CL

- Drug: Placebo

**Label:** BIIB 722 CL

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BIIB 722 CL

**Name:** BIIB 722 CL

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- BIIB 722 CL

- Placebo

**Description:** Hydroxypropyl-beta-cyclodextrin (HPβCD)

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of subjects with adverse events

**Time Frame:** up to 12 days after drug administration

**Description:** blood pressure, pulse rate, respiratory rate, oral body temperature

**Measure:** Number of subjects with clinically significant findings in vital signs

**Time Frame:** up to 12 days after drug administration

**Measure:** Number of subjects with clinically significant findings in ECG

**Time Frame:** up to 12 days after drug administration

**Measure:** Number of subjects with clinically significant findings in laboratory tests

**Time Frame:** up to 12 days after drug administration

#### Secondary Outcomes

**Measure:** Plasma concentration time profiles

**Time Frame:** up to 96 hours after drug administration

**Measure:** Maximum measured concentration of the analyte in plasma (Cmax)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Time from dosing to the maximum concentration of the analyte in plasma (tmax)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Terminal half-life of the analyte in plasma (t1/2)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Mean residence time of the analyte in the body (MRT)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Total clearance of the analyte in plasma (CL)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Apparent volume of distribution at steady state (Vss)

**Time Frame:** up to 96 hours after drug administration

**Measure:** Amount of drug excreted into urine (Ae)

**Time Frame:** up to 72 hours after drug administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy males
* 21 to 50 years of age
* Broca index \>= -20% and \<= +20%
* Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Diseases of the central nervous system or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial
* Participation in another trial with an investigational drug (\<= two months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 21 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M107438

- Name: Betadex

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
