Phase 1
N=21
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01254409 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Safety and Tolerability — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRM-151 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax |
25.5; 145; 225 | — |
| SECONDARY Tmax |
5.35; 1.30; 0.69 | — |
| SECONDARY AUC48 |
446; 2190; 4710 | — |
| SECONDARY Terminal Elimination Half Life |
21.7; 43.6; 71.6 | — |
| SECONDARY Total Body Clearance |
2.33; 1.59; 1.09 | — |
| SECONDARY Vss |
53.9; 73.9; 72.0 | — |
| SECONDARY FVC (Forced Vital Capacity) Change From Baseline to Day 57 |
-0.063; 0.058; 0.060; 0.078 | — |
| SECONDARY FVC (Forced Vital Capacity) % Predicted Change From Baseline |
-1.5; 2.4; 2.8; 1.8 | — |
| SECONDARY DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline |
-2.3; 0.2; -4.0; -1.5 | — |
| SECONDARY FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline |
-1.7; 2.6; 2.4; 0.3 | — |
| SECONDARY 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline |
-11; -11; 6; 35 | — |
| SECONDARY SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline |
-0.5; 2.3; 7.1; -6.3 | — |
Summary
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
Eligibility Criteria
Inclusion Criteria
- Men or women of non-childbearing potential aged 40 to 80 years at screening.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.
Exclusion Criteria
- History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
- History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
- High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).
Data sourced from ClinicalTrials.gov (NCT01254409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.