Cystic Fibrosis Treatment Report

www.CysticFibrosisTreatmentReport.com

Phase 1

Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)

https://clinicaltrials.gov/ct2/show/NCT02323100?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F19%2F2020&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: Ravicti low dose;   Drug: Ravicti high dose;   Drug: Placebo

Sponsors :   National Jewish Health;   University of Alabama at Birmingham;   Children’s Hospital of Philadelphia;   Johns Hopkins University;   Horizon Pharma Ireland, Ltd., Dublin Ireland

Recruiting

Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)

NCT02323100

Tue, 23 Dec 2014 12:00:00 EST

Last Update Posted: 04/02/20 09:29AM

Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03140527?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=08%2F26%2F2019&lupd_d=14

Conditions :   Healthy Volunteer;   Cystic Fibrosis

Interventions :   Drug: PTI-801;   Drug: Placebo;   Drug: PTI-808

Sponsor :   Proteostasis Therapeutics, Inc.

Recruiting

Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

NCT03140527

Thu, 04 May 2017 12:00:00 EDT

Last Update Posted: 09/09/19 10:07AM

A DDI Study of FDL169 and FDL176 in Healthy Subjects

https://clinicaltrials.gov/ct2/show/NCT03756922?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=07%2F18%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: FDL169;   Drug: FDL176

Sponsor :   Flatley Discovery Lab LLC

Recruiting

A DDI Study of FDL169 and FDL176 in Healthy Subjects

NCT03756922

Wed, 28 Nov 2018 12:00:00 EST

Last Update Posted: 08/01/19 08:36AM

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF)

https://clinicaltrials.gov/ct2/show/NCT04010799?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F24%2F2019&lupd_d=14

Conditions :   Cystic Fibrosis;   Non-Cystic Fibrosis Bronchiectasis

Interventions :   Drug: CHF 6333;   Drug: Placebo

Sponsor :   Chiesi Farmaceutici S.p.A.

Recruiting

A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis

NCT04010799

Mon, 08 Jul 2019 12:00:00 EDT

Last Update Posted: 07/08/19 07:51AM

Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03058068?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F10%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Biological: Allo-hMSCs;   Biological: Placebo

Sponsor :   Joshua M Hare

Not yet recruiting

Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis

NCT03058068

Mon, 20 Feb 2017 12:00:00 EST

Last Update Posted: 06/24/19 07:42AM

Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03251092?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=06%2F04%2F2019&lupd_d=14

Conditions :   Healthy Volunteer – Complete;   Cystic Fibrosis

Interventions :   Drug: PTI-808;   Drug: Placebo;   Drug: PTI-428;   Drug: PTI-801

Sponsor :   Proteostasis Therapeutics, Inc.

Recruiting

Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis

NCT03251092

Wed, 16 Aug 2017 12:00:00 EDT

Last Update Posted: 06/18/19 07:04AM

Glycerol Phenylbutyrate Corrector Therapy [Ravicti] For CF (Cystic Fibrosis)

https://clinicaltrials.gov/ct2/show/NCT02323100?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=05%2F28%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: Ravicti low dose;   Drug: Ravicti high dose;   Drug: Placebo

Sponsors :   National Jewish Health;   University of Alabama at Birmingham;   Children’s Hospital of Philadelphia;   Johns Hopkins University;   Horizon Pharma Ireland, Ltd., Dublin Ireland

Recruiting

Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)

NCT02323100

Tue, 23 Dec 2014 12:00:00 EST

Last Update Posted: 06/11/19 07:02AM

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients

https://clinicaltrials.gov/ct2/show/NCT02598999?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=04%2F17%2F2019&lupd_d=14

Conditions :   Cystic Fibrosis;   Bronchiectasis

Interventions :   Drug: ALX-009;   Drug: OSCN-;   Drug: bLF;   Drug: Placebo

Sponsor :   Alaxia SAS

Recruiting

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients

NCT02598999

Fri, 06 Nov 2015 12:00:00 EST

Last Update Posted: 05/01/19 07:29AM

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03768089?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F25%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: VX-121;   Drug: TEZ/IVA;   Drug: IVA;   Drug: Matched Placebo

Sponsor :   Vertex Pharmaceuticals Incorporated

Active, not recruiting

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

NCT03768089

Fri, 07 Dec 2018 12:00:00 EST

Last Update Posted: 04/08/19 08:27AM

Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03375047?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=03%2F07%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: MRT5005;   Drug: Normal saline

Sponsor :   Translate Bio, Inc.

Recruiting

Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis

NCT03375047

Fri, 15 Dec 2017 12:00:00 EST

Last Update Posted: 03/21/19 09:54AM

A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Patients With Cystic Fibrosis

https://clinicaltrials.gov/ct2/show/NCT03647228?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F22%2F2019&lupd_d=14

Condition :   Healthy Subjects

Interventions :   Drug: IONIS-ENaCRx;   Drug: Placebo

Sponsor :   Ionis Pharmaceuticals, Inc.

Recruiting

A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis

NCT03647228

Mon, 27 Aug 2018 12:00:00 EDT

Last Update Posted: 03/08/19 11:56AM

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

https://clinicaltrials.gov/ct2/show/NCT03669614?recrs=abdf&type=Intr&cond=Cystic+Fibrosis&lupd_s=02%2F12%2F2019&lupd_d=14

Condition :   Cystic Fibrosis

Interventions :   Drug: inhaled AR-501;   Drug: inhaled AR-501 placebo

Sponsor :   Aridis Pharmaceuticals, Inc.

Recruiting

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

NCT03669614

Thu, 13 Sep 2018 12:00:00 EDT

Last Update Posted: 02/26/19 10:27AM

A DDI Study of FDL169 and FDL176 in Healthy Subjects

https://clinicaltrials.gov/ct2/show/NCT03756922

Sponsor:
Flatley Discovery Lab LLC
Information provided by (Responsible Party):
Flatley Discovery Lab LLC

Brief Summary:
A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis
Drug: FDL169
Drug: FDL176
Phase 1

Detailed Description:
This is an open-label, non-randomised study. Enrolment will be in two parallel and independent parts. Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL169 with and without co-administration of FDL176.

Study Design

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

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