Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Nycomed

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Teduglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01028768

TE-1777-101-EC

Details and patient eligibility

About

To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.

Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Full description

Pharmacokinetic study.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects with moderate, severe and end stage renal failure and matched healthy controls.

Trial design

36 participants in 1 patient group

Teduglutide

Experimental group

Treatment:

Drug: Teduglutide