Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

NCT01028924 | Completed Phase 1

• 1 other identifier: TE-1777-102-EC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.

Conditions

Healthy

Keywords

Thorough QTc-Study; Short Bowel Syndrome; Cardiac safety

Outcome Measures

Primary Outcomes (1)

• ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).

  until 24 h post dose

Secondary Outcomes (5)

• ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction

  until 24 h post dose

• ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)

  until 24 h post dose

• PK blood samples to investigate pharmacokinetics of teduglutide in plasma

  until 24 h post dose

• PK blood samples to explore the concentration effect relationship on QT/QTc intervals

  until 24 h post dose

• ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide

  within 14 days after trial medication administration

Study Arms (4)

Teduglutide 5 mg

EXPERIMENTAL

Treatment A, subcutaneous injection

Drug: Teduglutide

Teduglutide 20 mg

EXPERIMENTAL

Treatment B, subcutaneous injection

Drug: Teduglutide

Placebo

PLACEBO COMPARATOR

subcutaneous injection

Drug: Teduglutide

Moxifloxacin

ACTIVE COMPARATOR

400 mg, oral

Drug: Teduglutide

Interventions

Teduglutide DRUG

subcutaneous (SC), single dose

Moxifloxacin; Placebo; Teduglutide 20 mg; Teduglutide 5 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteers
• Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight \>50 kg (females) and \>60 kg (males).

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed GmbH

Konstanz, 78467, Germany

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 7, 2012

Record last verified: 2010-04

Locations

DE (1)