Clinical trial NCT01644240: 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
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Intravenous Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Gastrointestinal Motility Disorder
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Cmax
timeFrame: Day 1
measure: Tmax
timeFrame: Day 1
measure: t½
timeFrame: Day 1
measure: AUC0-24
timeFrame: Day 1
measure: AUC0-∞
timeFrame: Day 1
measure: AUCtau
timeFrame: Day 1
measure: Plasma Vz
timeFrame: Day 1
measure: Plasma CL
timeFrame: Day 1
measure: Cmax
timeFrame: Day 5
measure: Tmax
timeFrame: Day 5
measure: t½
timeFrame: Day 5
measure: AUC0-24
timeFrame: Day 5
measure: AUC0-∞
timeFrame: Day 5
measure: AUCtau
timeFrame: Day 5
measure: Vss
timeFrame: Day 5
measure: CLss
timeFrame: Day 5
Secondary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: 1 week
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
Study officials:
affiliation: Theravance Biopharma, US, Inc.
name: Brett Haumann, SVP, Clinical Development
role: STUDY_DIRECTOR
References: