Drug-Drug Interaction (DDI) Study for TD-9855

Phase 1

Completed

• Conditions: Drug Drug Interaction (DDI)
• Interventions: Drug: TD-9855; Drug: Fluvoxamine; Drug: Itraconazole; Drug: Caffeine

• Registration Number: NCT03432793
• Lead Sponsor: Theravance Biopharma

Brief Summary

This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-14
• Study Start: 2018-02-28
• Primary Completion: 2018-04-21
• Study Completion: 2018-04-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

• Willing and able to give written, signed informed consent
• Male subjects 19 to 55 years of age (inclusive)
• Body mass index 19 to 32 kg/m2 (inclusive), and weigh at least 55 kg
• No clinically important abnormal physical findings as determined by the Principal Investigator (PI) at the screening and Day -1 examinations
• Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
• No clinically important laboratory abnormalities as determined by the PI
• Ability to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and direction of the clinic staff
• Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
• Male smokers: Subjects who self-report to have smoked > 9 cigarettes per day for at least 6 month prior to screening as confirmed by urine cotinine test at screening and Day -1.
• Male smokers: Subjects must be willing to continue consistent use of their tobacco products throughout the study.
• Additional inclusion criteria apply

Exclusion Criteria

• Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
• History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, hematologic, neurologic (including history of seizure and insomnia), cardiovascular (including postural orthostatic hypotension or tachycardia), psychiatric (including depression and known addictive disorders), musculoskeletal, genitourinary (including urinary retention), immunologic, or dermatologic disorder.
• Any other condition that, in the opinion of the PI, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
• Any history of suicide attempts/ideation or current suicidal ideation.
• Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half-lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
• Additional inclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-9855 + Fluvoxamine + Caffeine	Fluvoxamine	Male smokers will receive TD-9855, fluvoxamine, and caffeine
TD-9855 + Fluvoxamine + Caffeine	TD-9855	Male smokers will receive TD-9855, fluvoxamine, and caffeine
TD-9855 + Itraconazole + Caffeine	TD-9855	Male non-smokers will receive TD-9855, itraconazole, and caffeine
TD-9855 + Itraconazole + Caffeine	Itraconazole	Male non-smokers will receive TD-9855, itraconazole, and caffeine
TD-9855 + Fluvoxamine + Caffeine	Caffeine	Male smokers will receive TD-9855, fluvoxamine, and caffeine
TD-9855 + Itraconazole + Caffeine	Caffeine	Male non-smokers will receive TD-9855, itraconazole, and caffeine

Primary Outcome Measures

Name	Time	Method
Change in TD-9855 plasma exposure when administered with itraconazole or fluvoxamine	Day 9 and Day 24

Secondary Outcome Measures

Name	Time	Method
Correlation between caffeine PK disposition and TD-9855 plasma exposure	Day 9 and Day 24	Correlation co-efficient will be calculated between caffeine/paraxanthine ratio at 4hr after caffeine dose and TD-9855 plasma AUC on Day 9 and Day 24.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States