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

NCT03432793 | Completed Phase 1 FDA Drug

• 1 other identifier: 0172
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Drug Interaction (DDI)

Keywords

DDI; Itraconazole; Fluvoxamine; TD-9855; Smoking; Caffeine; CYP1A2; CYP3A4

Outcome Measures

Primary Outcomes (1)

• Change in TD-9855 plasma exposure when administered with itraconazole or fluvoxamine

  Day 9 and Day 24

Secondary Outcomes (1)

• Correlation between caffeine PK disposition and TD-9855 plasma exposure

  Day 9 and Day 24

Study Arms (2)

TD-9855 + Fluvoxamine + Caffeine

EXPERIMENTAL

Male smokers will receive TD-9855, fluvoxamine, and caffeine

Drug: TD-9855; Drug: Fluvoxamine; Drug: Caffeine

TD-9855 + Itraconazole + Caffeine

EXPERIMENTAL

Male non-smokers will receive TD-9855, itraconazole, and caffeine

Drug: TD-9855; Drug: Itraconazole; Drug: Caffeine

Interventions

TD-9855 DRUG

oral tablet, QD

TD-9855 + Fluvoxamine + Caffeine; TD-9855 + Itraconazole + Caffeine

Fluvoxamine DRUG

oral tablet, QD

TD-9855 + Fluvoxamine + Caffeine

Itraconazole DRUG

oral tablet solution, QD

TD-9855 + Itraconazole + Caffeine

Caffeine DRUG

oral solution, single dose

TD-9855 + Fluvoxamine + Caffeine; TD-9855 + Itraconazole + Caffeine

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

ampreloxetine; Fluvoxamine; Itraconazole; Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 14, 2018
• Study Start: February 28, 2018
• Primary Completion: April 21, 2018
• Study Completion: April 21, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)