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Drug & research development » Clinical trials » NCT02227888

PK Study of N91115 in Cystic Fibrosis Patients (SNO3)

Official title: A Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis Patients

Clinical Trials gov number: NCT02227888

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Purpose: A Phase 1 study in F508del-CFTR homozygous CF patients to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase 2 trials.

Phase: 1

Type: Interventional, open-label, single group assignment

Study sponsor: Nivalis Therapeutics, Inc.

  • Confirmed diagnosis of CF, homozygous for the F508del-CFTR mutation
  • Weight ≥ 40 kg at screening
  • FEV1 ≥ 40% of predicted normal for age, gender, and height (Hankinson standards) pre or post-bronchodilator value, at screening
  • Hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening

Intervention
N91115

Geographical Location
United States

Number of Participants
≤50 (≥18 years)

Primary Endpoint

Pharmacokinetics (14 days)

Secondary Endpoint

Safety of dosing twice per day over 14 days

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  • Experimental: N91115 every 12 hour oral dosing of 50 mg N91115 for 14 days
View Trial Results