Faldaprevir

Generic Name: Faldaprevir

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₄₀H_₄₉BrN_₆O_₉S

CAS Number: 801283-95-4

Unique Ingredient Identifier: 958X4J301A

Background: Faldaprevir has been investigated for the treatment of Chronic Hepatitis C.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection

Phase 2

Completed

Conditions: Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Hepatitis C Viral Infection

Interventions: Drug: Faldaprevir
Drug: TD-6450
Drug: Ribavirin

First Posted Date: 2016-03-23

Last Posted Date: 2017-10-17

Lead Sponsor: Trek Therapeutics, PBC

Target Recruit Count: 25

Registration Number: NCT02716428

Locations: 🇺🇸
Southern California Research Center, Coronado, California, United States
🇺🇸
Bach and Godofsky Infectious Diseases, Bradenton, Florida, United States
🇳🇿
Auckland Clinical Studies, Auckland, New Zealand

and more 3 locations

A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

Phase 2

Completed

Conditions: Hepatitis C Viral Infection
Chronic Hepatitis C
Hepatitis C Genotype 4
Hepatitis C (HCV)

Interventions: Drug: Faldaprevir
Drug: TD-6450
Drug: Ribavirin

First Posted Date: 2015-10-30

Last Posted Date: 2017-01-30

Lead Sponsor: Trek Therapeutics, PBC

Target Recruit Count: 16

Registration Number: NCT02593162

Locations: 🇺🇸
Southern California Research Center, Coronado, California, United States

Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Faldaprevir
Drug: Cyclosporine
Drug: Tacrolimus

First Posted Date: 2013-12-20

Last Posted Date: 2016-05-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 32

Registration Number: NCT02016625

Locations: 🇩🇪
1241.61.1 Boehringer Ingelheim Investigational Site, Mannheim, Germany

Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 207127
Drug: Moxifloxacin (Avalox®)
Drug: BI 207127 placebo
Drug: Faldaprevir placebo
Drug: Faldaprevir

First Posted Date: 2013-10-18

Last Posted Date: 2016-04-14

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 48

Registration Number: NCT01965431

Locations: 🇩🇪
1241.40.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

Phase 1

Terminated

Conditions: Renal Insufficiency

Interventions: Drug: BI 207127
Drug: faldaprevir

First Posted Date: 2013-10-08

Last Posted Date: 2016-04-11

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 4

Registration Number: NCT01957657

Locations: 🇩🇪
1241.32.1 Boehringer Ingelheim Investigational Site, Kiel, Germany

Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: faldaprevir
Drug: Microgynon®
Drug: BI 207127

First Posted Date: 2013-09-13

Last Posted Date: 2016-04-11

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 18

Registration Number: NCT01941615

Locations: 🇩🇪
1241.31.2 Boehringer Ingelheim Investigational Site, Mannheim, Germany

Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C

Phase 2

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: PPI-668
Drug: BI 207127 Dose 1
Drug: BI 207127 Dose 2
Drug: Faldaprevir
Drug: Ribavirin
Drug: BI 207127 Placebo

First Posted Date: 2013-05-22

Last Posted Date: 2015-11-25

Lead Sponsor: Presidio Pharmaceuticals, Inc.

Target Recruit Count: 38

Registration Number: NCT01859962

Locations: 🇺🇸
Quest Clinical Research, San Francisco, California, United States

BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

Phase 2

Completed

Conditions: Hepatitis C, Chronic

Interventions: Drug: Ribavirin
Drug: BI 207127 high dose
Drug: BI 207127 low dose
Drug: Faldaprevir

First Posted Date: 2013-04-12

Last Posted Date: 2015-11-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 35

Registration Number: NCT01830127

Locations: 🇺🇸
1241.30.10001 Boehringer Ingelheim Investigational Site, Deland, Florida, United States
🇩🇪
1241.30.49004 Boehringer Ingelheim Investigational Site, Berlin, Germany
🇩🇪
1241.30.49008 Boehringer Ingelheim Investigational Site, Bonn, Germany

and more 16 locations

Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Itraconazole
Drug: Atorvastatin
Drug: Faldaprevir
Drug: Rosuvastatin

First Posted Date: 2013-02-21

Last Posted Date: 2015-08-03

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 51

Registration Number: NCT01795937

Locations: 🇩🇪
1220.61.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany

Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Raltegravir
Drug: Faldaprevir

First Posted Date: 2013-02-07

Last Posted Date: 2015-08-03

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 25

Registration Number: NCT01785160

Locations: 🇩🇪
1220.65.1 Boehringer Ingelheim Investigational Site, Mannheim, Germany

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