Hepatic Impairment Clinical Trial
Official title:
The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
| NCT number | NCT02581592 |
| Other study ID # | 0134 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | November 2015 |
| Est. completion date | April 2016 |
| Verified date | February 2022 |
| Source | Viatris Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B) - For normal hepatic function group: Subject is in good health Exclusion Criteria: - Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study. - Subject has received an investigational drug (or medical device) within 30 days - Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Orlando Clinical Research Center (OCRD) | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Mylan Inc. | Theravance Biopharma |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | TD-4208 Cmax, derived from plasma concentration-time curves | Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose | |
| Secondary | Adverse Events (AE) | An AE is any unfavorable and unintended change in the body temporally associated with study drug administration, whether or not considered related to the study drug | From the time of study drug administration through the end of the study (Day 5 or early termination) |
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