rhGH Therapy on Hepatic Drug Metabolism

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Brief Title

rhGH Therapy on Hepatic Drug Metabolism

Official Title

Recombinant Human Growth Hormone Therapy and Drug Metabolism

Brief Summary

      The purpose of the study is to understand the effect of rhGH therapy on hepatic drug
      metabolism in children with idiopathic growth hormone deficiency.
    

Detailed Description

      Growth Hormone (GH) deficiency is a prominent cause of short stature, affecting approximately
      14,000 children in the US. Although a single study has demonstrated reduces CYP1A2 activity
      following Gh replacement therapy, the effect of GH on the most abundant phase 1
      biotransformation pathways (e.g. CYP2D6 and CYP3A4) remain largely uncharacterized. This
      information gap exists largely due to the lack of sufficiently safe, specific and
      non-invasive methods appropriate for the longitudinal evaluation of enzyme activity in young
      children. We can overcome these problems by employing validated phenotyping methods using
      caffeine, a commonly ingested dietary substance and dextromethorphan, a safe, non-sedating
      over the counter anti-tussive agent. Application of these methods will permit us to identify,
      characterize and describe the isoform-specific effects of rhGH on major phase 1 hepatic drug
      biotransformation pathways, thereby addressing this information gap with minimal risk to
      children.
    


Study Type

Observational




Condition

Growth Hormone Deficiency, Dwarfism

Intervention

Dextromethorphan and Caffeine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

June 2001

Completion Date

September 2008

Primary Completion Date

September 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Children ages 4 to 14 years with a height less than the 5th percentile for age and sex
             or having a decelerated across two major percentiles (5th, 10th, 25th, 50th, 90th, and
             95th) on standard pediatric growth curves, poor growth velocity (less than 5
             centimeters/year), radiographic evidence of delayed bone age (i.e. greater than 1 SD
             below the mean for chronological age) and a documented diagnosis of idiopathic growth
             hormone deficiency [as determined by failure to raise serum GH concentrations 10
             microgram/Liter following provocative testing with two growth hormone
             secretagogues(e.g. insulin, arginine, or clonidine)].

          -  All subjects will be prepubertal, as determined by Tanner staging.

        Exclusion Criteria:

          -  Children receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO,
             CYP2D6 or CYP3A4 activity.

          -  Subjects with a history of smoking (including exposure to second hand smoke > 8 hours
             per day) or illicit drug use.

          -  Subjects with a history of hepatic, renal, cardiac or thyroid disorders. Presence of
             hepatic, renal, cardiac or thyroid disease will be established based on clinical
             history and results of recent laboratory tests conducted as part of the routine
             medical evaluation of children who are being considered for rhGH therapy.

          -  Children experiencing fever or acute viral illness

          -  Children who have a history of a hypersensitivity reaction to dextromethorphan or
             caffeine

          -  Children who have received prior treatment with rhGH

          -  Children who are receiving corticosteroids or thyroid hormone
      

Gender

All

Ages

4 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

Mary J Kennedy, PharmD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00458991

Organization ID

PPRU 10734

Secondary IDs

U10HD045934-01

Responsible Party

Sponsor

Study Sponsor

University of Louisville

Collaborators

 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor

Mary J Kennedy, PharmD, Principal Investigator, Virginia Commonwealth University


Verification Date

April 2017