TerminatedPhase 2

Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Stopped: Business decision pending resolution of clinical hold with FDA

United States2 participantsStarted 2020-12-03

Plain-language summary

To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. chronic cough
✓. fatigue
✓. frequent throat clearing
✓. shortness of breath (dyspnea)
✓. coughing up of blood (hemoptysis)
✓. excessive mucus (sputum) production
✓. fever
✓. night sweats

What they're measuring

Maximum Plasma Concentration (Cmax) of SPR719

Timeframe: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose

Time to Reach Maximum Plasma Concentration (Tmax) of SPR719

Timeframe: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose

Area Under the Concentration-time Curve From Zero to Tau, Where Tau is the Dosing Interval (AUC0-tau) for SPR719

Timeframe: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose

Accumulation Ratio of SPR719

Timeframe: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose

Trial details

NCT IDNCT04553406

SponsorSpero Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-28

Results submitted2022-02-03

View on ClinicalTrials.gov More Mycobacterium Avium Complex trials