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

Sponsored by:	NPS Pharmaceuticals
Information provided by:	NPS Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00820885

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics and Safety of Elevated Doses	Drug: teduglutide Drug: tedguglutide	Phase I

Drug Information available for: Teduglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:

Each dose arm is safe [ Time Frame: Within 1 week of each cohort completion ] [ Designated as safety issue: Yes ]

Enrollment:	95
Study Start Date:	July 2006
Study Completion Date:	May 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
Cohort F 30mg in 50mg/ml concentration and placebo	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.
Cohort H 50mg in 50mg/ml concentration and placebo	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.
cohort I 80mg in 50mg/ml concentration and placebo	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.

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820885

Locations

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

Sponsors and Collaborators

NPS Pharmaceuticals

Investigators

Principal Investigator:

Paula Shaw, M.D.

Investigator with Northwest Kinetics

More Information

Responsible Party:	NPS Pharmaceuticals ( John L. Wallens, Director of Clinical Operations )
Study ID Numbers:	CL0600-022
Study First Received:	January 8, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820885
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009