Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 7/13/2016 |
| Start Date: | November 2015 |
| End Date: | April 2016 |
The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
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.
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.
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.
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