Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Hepatic Impairment Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose. |
Drug: TD-4208
A single inhaled dose of TD 4208 (175 mcg)
Other Names:
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Experimental: Normal Hepatic Function Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose. |
Drug: TD-4208
A single inhaled dose of TD 4208 (175 mcg)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) [Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose]
TD-4208 Cmax, derived from plasma concentration-time curves
Secondary Outcome Measures
- Adverse Events (AE) [From the time of study drug administration through the end of the study (Day 5 or early termination)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
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For normal hepatic function group: Subject is in good health
Exclusion Criteria:
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Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
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Subject has received an investigational drug (or medical device) within 30 days
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Orlando Clinical Research Center (OCRD) | Orlando | Florida | United States | 32809 |
Sponsors and Collaborators
- Mylan Inc.
- Theravance Biopharma
Investigators
- Study Director: Medical Monitor, Theravance Biopharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0134