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

Shire

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics and Safety of Elevated Doses

Treatments: Drug: teduglutide; Drug: tedguglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820885

CL0600-022

Details and patient eligibility

About

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 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.

Enrollment: 95 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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95 participants in 8 patient groups

cohort A

Other group

Description:

20 mg dose 20 mg/ML concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort AR

Other group

Description:

20 mg in 50 mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort C

Other group

Description:

25 mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort D

Other group

Description:

15 mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort E

Other group

Description:

10 mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort F

Other group

Description:

30mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

Cohort H

Other group

Description:

50mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide

cohort I

Other group

Description:

80mg in 50mg/ml concentration and placebo

Treatment:

Drug: teduglutide

Drug: tedguglutide

Drug: teduglutide