NCT03691584

Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers

A Phase 1, Open-label, Randomized, PK and Safety Study To Assess Bronchopulmonary Disposition of Intravenous TP-6076 in Healthy Men and Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample.

Detailed description

This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample. The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4). Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. The BAL will be conducted in 5 different subjects at each of the 4 time points, adding up to a total of 20 subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TP-6076	The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).
PROCEDURE	Bronchoalveolar lavage	Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-06-30
• Completion: 2019-12-18
• First posted: 2018-10-02
• Last updated: 2021-12-17

Locations

1 site across 1 country: United Kingdom