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

May 24, 2021 updated by: Shire
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: cohort A
20 mg dose 20 mg/ML concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort AR
20 mg in 50 mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort C
25 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort D
15 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort E
10 mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort F
30mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: Cohort H
50mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex
Other: cohort I
80mg in 50mg/ml concentration and placebo
Drug: teduglutide
subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
Other Names:
  • Gattex is the brand name
Drug: teduglutide
Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
Other Names:
  • Gattex
Drug: tedguglutide
lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other Names:
  • Gattex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Each dose arm is safe
Time Frame: Within 1 week of each cohort completion
Within 1 week of each cohort completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL0600-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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