Clinical trial NCT01702194: TD-1211 IV/Oral Mass Balance Study
Official title: A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: OIC
Keywords: OIC
Opioid Induced Constipation
Constipation
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine TD-1211 is processed by the body.

Detailed description: This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.

Eligibility criteria: Inclusion Criteria:

1. Healthy, nonsmoking male, 18 to 50 years old, inclusive.
2. Agrees to use a highly effective method of birth control.
3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
4. Willing and able to give written informed consent.

Exclusion Criteria:

1. Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
2. Hemoglobin \<14.1 g/dL or hematocrit \< 40.6% at Screening.
3. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
4. Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]).
5. Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0 to 168 hours postdose
measure: Peak plasma concentration (Cmax)
timeFrame: 0 to 168 hours postdose
measure: Time to peak plasma concentration (Tmax)
timeFrame: 0 to 168 hours postdose
measure: Half-life (T 1/2)
timeFrame: 0 to 168 hours postdose
measure: Percent total recovery of radioactivity in blood, urine, and feces
timeFrame: 0 to 312 hours postdose
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance
state: Wisconsin
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: