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TerminatedNCT02268604Updated Oct 20, 2014

Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers

A Phase 1 interventional study of BIIB 722 CL and Placebo in Healthy, sponsored by Boehringer Ingelheim. Terminated. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy males
  • 18 to 55 years of age
  • Broca index >= -20% and \<= +20%
  • Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • 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 1 month prior to administration
  • Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within 2 months prior to administration of during trial
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation within 1 month prior to administration or during the trial
  • Excessive physical activities within 5 days prior to administration or during the trial
  • Any laboratory value outside the clinically accepted reference range
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
10 participants (actual)

Study arms

  • Experimental
    BIIB 722 CL

    Drug: BIIB 722 CL

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBIIB 722 CL
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma (AUC)

    Time frame: up to day 7

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to day 7

  3. Time to maximum measured concentration of the analyte in plasma (tmax)

    Time frame: up to day 7

  4. Total mean residence time of the analyte in the body (MRTtot)

    Time frame: up to day 7

  5. Total clearance of the analyte in plasma (CLtot/f)

    Time frame: up to day 7

  6. Terminal half-life of the analyte in plasma (t1/2)

    Time frame: up to day 7

  7. Amount of the analyte excreted in urine (Ae)

    Time frame: up to day 7

  8. Dose proportionality

    assessed by AUC

    Time frame: up to day 7

  9. Accumulation factor

    (predose concentration/concentration after 8 hours)

    Time frame: up to day 7

  10. Time to reach steady state

    Time frame: up to day 7

  11. Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery

    in vitro fluorescence

    Time frame: up to day 7

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: up to day 12

  2. Number of subjects with clinically significant findings in vital functions

    Time frame: up to day 12

  3. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to day 12

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02268604
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 20, 2014
Start date
Oct 2010
Primary completion
Oct 2010
Last update
Oct 20, 2014
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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