A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects

NCT ID: NCT01644240

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-12-31

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.

Conditions

Gastrointestinal Motility Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

TD-8954 Dose 1

Group Type: EXPERIMENTAL

TD-8954

Intervention Type: DRUG

Intravenous infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo - saline

Intervention Type: DRUG

Intravenous infusion

TD-8954 Dose 2

Group Type: EXPERIMENTAL

TD-8954

Intervention Type: DRUG

Intravenous infusion

Interventions

TD-8954

Intravenous infusion

Intervention Type: DRUG

Placebo - saline

Intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.

2. Body mass index (BMI)between 18 to 36 kg/m2, inclusive.

3. Average frequency of ≥ 3 bowel movements per week.

Exclusion Criteria

1. Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.

2. History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Haumann, SVP, Clinical Development

Role: STUDY_DIRECTOR

Theravance Biopharma, US, Inc.

Locations

Miami Research Associates

Miami, Florida, United States

Countries

United States

Other Identifiers

0095

Identifier Type: -

Identifier Source: org_study_id