TD-9855 Mass Balance Study

NCT01924143 | Completed Phase 1 FDA Drug

• 1 other identifier: 0105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]TD-9855

Conditions

ADHD; Fibromyalgia

Keywords

ADHD; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855

  Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.

  1-21 Days

Secondary Outcomes (9)

• Pharmacokinetics of total drug-related material and TD-9855: Cmax

  1-21 Days

• PK: Tmax

  1-21 Days

• PK: AUCt

  1-21 Days

• PK: AUCinf

  1-21 Days

• PK: CL/F (Renal clearance)

  1-21 Days

Study Arms (1)

TD-9855

EXPERIMENTAL

Drug: TD-9855

Interventions

TD-9855 DRUG

radiolabeled (100 µCi \[14C\]-Labeled) TD-9855 (20 mg)

TD-9855

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone \[FSH\] \>40 IU/mL)
• Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
• Negative for hepatitis B, hepatitis C, and HIV antibody

You may not qualify if:

• Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
• Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
• Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
• Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Fibromyalgia

Interventions

ampreloxetine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)