NCT00990990

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PNU-100480 (PF-02341272) After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects

Completed Phase 1 Last updated 27 August 2013

What this trial tests

Phase 1 trial testing PNU-100480 in Tuberculosis in 59 participants. Completed in 1 May 2010.

Timeline

1 October 2009

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	Sequella, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	59
Start date	1 October 2009
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	1 location across United States

Drugs / interventions tested

• PNU-100480 — full drug profile →
• Placebo
• PNU-100480 — full drug profile →
• Placebo
• PNU-100480 — full drug profile →
• Placebo
• PNU-100480 — full drug profile →
• Placebo
• PNU-100480 — full drug profile →
• Placebo
• PNU-100480 — full drug profile →
• Placebo
• Linezolid — full drug profile →

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Sequella, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Tuberculosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers.
  Time frame: Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed

Sponsor's own description

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. New agents for the treatment of drug-resistant Mycobacterium tuberculosis.
   Hoagland DT, Liu J, Lee RB, Lee RE. · · 2016 · cited 218× · PMID 27151308 · DOI 10.1016/j.addr.2016.04.026
2. Biomarker-assisted dose selection for safety and efficacy in early development of PNU-100480 for tuberculosis.
   Wallis RS, Jakubiec W, Kumar V, Bedarida G, et al · · 2011 · cited 86× · PMID 21078950 · DOI 10.1128/aac.01179-10
3. Current development and future prospects in chemotherapy of tuberculosis.
   Nuermberger EL, Spigelman MK, Yew WW. · · 2010 · cited 43× · PMID 20546189 · DOI 10.1111/j.1440-1843.2010.01775.x
4. Antituberculosis therapy for 2012 and beyond.
   Lauzardo M, Peloquin CA. · · 2012 · cited 15× · PMID 22332895 · DOI 10.1517/14656566.2012.657176
5. New drugs and regimens for treatment of TB.
   Leibert E, Rom WN. · · 2010 · cited 15× · PMID 20586565 · DOI 10.1586/eri.10.60
6. Revolutionizing tuberculosis treatment: Breakthroughs, challenges, and hope on the horizon.
   Kufa M, Finger V, Kovar O, Soukup O, et al · · 2025 · cited 6× · PMID 40370552 · DOI 10.1016/j.apsb.2025.01.023