SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TD-1473 for SAD; Drug: Placebo for SAD; Drug: TD-1473 for MAD; Drug: Placebo for MAD

• Registration Number: NCT02657122
• Lead Sponsor: Theravance Biopharma

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study Start: 2015-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy male or female 19 to 55 years old
• Willing and able to give informed consent
• Body Mass Index (BMI) 18 to 30 kg/m2
• Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
• Additional inclusion criteria apply

Exclusion Criteria

• Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
• Clinically significant abnormalities in baseline results of laboratory evaluations
• Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
• Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
• Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
• Additional exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-1473 for SAD	TD-1473 for SAD	6 of out 8 subjects per cohort will be randomized to receive TD-1473
Placebo for SAD	Placebo for SAD	2 of out 8 subjects per cohort will be randomized to receive placebo
TD-1473 for MAD	TD-1473 for MAD	6 of out 8 subjects per cohort will be randomized to receive TD-1473
Placebo for MAD	Placebo for MAD	2 of out 8 subjects per cohort will be randomized to receive placebo

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs	Day 1 through Day 8 (SAD) or 21 (MAD)

Secondary Outcome Measures

Name	Time	Method
Amount excreted in urine (Aeu)	Day 1 through Day 4-6 (SAD)
Aeu	Day 1 through Day 17-19 (MAD)
Area under curve (AUC) in plasma, urine and feces	Day 1 through Day 4-6 (SAD)
AUC in plasma, urine and feces	Day 1 through Day 17-19 (MAD)
Terminal elimination half-life (t1/2) in plasma, urine and feces	Day 1 through Day 4-6 (SAD)
Amount excreted in feces (Aef)	Day 1 through Day 4-6 (SAD)
Aef	Day 1 through Day 17-19 (MAD)
Cmax in plasma, urine and feces	Day 1 through Day 17-19 (MAD)
Tmax in plasma, urine and feces	Day 1 through Day 17-19 (MAD)
t1/2 in plasma, urine and feces	Day 1 through Day 17-19 (MAD)

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States