A Double-Blind Multi-Dose Tolerability and Pharmacokineti... | NCT00820885

Studies
A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

NCT00820885

Sponsor

Shire

Status

Completed

Last Update Posted

May 25, 2021Actual

Enrollment

95Actual

Phase

Phase 1

Conditions

Pharmacokinetics and Safety of Elevated Doses

Interventions

teduglutide
teduglutide
tedguglutide

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

May 2021

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

Sep 6, 2006Actual

Primary Completion Date

Apr 23, 2007Actual

Completion Date

Apr 23, 2007Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 9, 2009

First Posted Date

Jan 12, 2009Estimated

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

May 24, 2021

Last Update Posted Date

May 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Detailed Description

Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

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

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort A	Other	20 mg dose 20 mg/ML concentration and placebo	Drug: teduglutide Drug: tedguglutide
Cohort AR	Other	20 mg in 50 mg/ml concentration and placebo	Drug: teduglutide Drug: tedguglutide
Cohort C	Other	25 mg in 50mg/ml concentration and placebo	Drug: teduglutide Drug: tedguglutide
Cohort D	Other	15 mg in 50mg/ml concentration and placebo	Drug: teduglutide Drug: tedguglutide
Cohort E	Other	10 mg in 50mg/ml concentration and placebo	Drug: teduglutide Drug: tedguglutide
Cohort F	Other	30mg in 50mg/ml concentration and placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
teduglutide	Drug	subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.	Cohort AR Cohort C Cohort D Cohort E

Measure	Description	Time Frame
Each dose arm is safe		Within 1 week of each cohort completion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women between 20 and 55 years of age
BMI of 18-35 inclusive
Able to understand and sign informed consent form
Willing and able to be confined at the clinical research center 8.5 days
Women who are post-menopausal, surgically sterilized, or agree to use effective form of birth control
Women of child bearing potential with a negative pregnancy test at screening and check-in
Medically healthy with normal clinical results and ECG/lab profiles at screening and check-in

Exclusion Criteria

Donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study
Pregnancy or become pregnant
Participated in another investigational trial 30 days prior
Physical examination/medical history indicates clinical condition or concurrent illness unsuitable for study
History/presence of clincally significant disease of any body system
History/evidence of congenital hon-hemolytic hyperbilirubinemia
History/evidence of gall stone disease, stomach or intestinal surgery
History/evidence of colorectal cancer
History/evidence of GI disease, e.g., malabsorption, Crohn's Disease, etc.
History/evidence of skin rashes or dermatitis
Taking prescription or over the counter medication (with the exception of oral contraception) during the 7 days preceding confinement to the clinical unit

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C494910	teduglutide
C438272	ALX-0600