Current partner codePEPTIDESDE
NCT00820885·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

95

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

teduglutide

subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.

DRUG

teduglutide

Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water

DRUG

tedguglutide

lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.

Timeline

From registration to results.

  1. First posted

    Jan 12, 2009

  2. Study start

    Sep 6, 2006

  3. Primary completion

    Apr 23, 2007

  4. Study completion

    Apr 23, 2007

  5. Results posted

    Not reported

  6. Registry updated

    May 25, 2021

Outcomes

What the study measures.

Primary outcomes

Each dose arm is safe

Time frame · Within 1 week of each cohort completion

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
Yes

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Northwest Kinetics

Tacoma, Washington, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teduglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.