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A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675581
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.

Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Drug: Microgynon Drug: Nintedanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Actual Study Start Date : November 8, 2018
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 10, 2019


Arm Intervention/treatment
Experimental: All subjects Drug: Microgynon
fixed sequence trial

Drug: Nintedanib
fixed sequence trial




Primary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve of the analyte (ethinylestradiol) in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 48 hours ]
  2. AUC0-tz (area under the concentration-time curve of the analyte (levonorgestrel) in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 48 hours ]
  3. Cmax (maximum measured concentration of the analyte (ethinylestradiol) in plasma) [ Time Frame: Up to 48 hours ]
  4. Cmax (maximum measured concentration of the analyte (levonorgestrel) in plasma) [ Time Frame: Up to 48 hours ]

Secondary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte (ethinylestradiol) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 48 hours ]
  2. AUC0-∞ (area under the concentration-time curve of the analyte (levonorgestrel) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 48 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • A woman of non-child bearing potential, i.e. being postmenopausal1 or permanently sterilised (e.g. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or a woman of childbearing potential correctly and consistently using a highly effective method of non-hormonal birth control (i.e. IUD or bilateral tubal ligation) together with barrier methods at least 30 days prior to first administration of Microgynon® (Visit 2), during the trial and for 3 months after last intake of nintedanib.
  • 2013 American College of Rheumatology (ACR) / European League against Rheumatism (EULAR) classification criteria for Systemic Sclerosis associated Interstitial Lung Disease (SSc) fulfilled
  • SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung >= 10%
  • Forced Vital Capacity (FVC) >= 40% of predicted normal
  • Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
  • Further inclusion criteria apply

Exclusion criteria:

  • Aspartate Transaminase (AST), Alanine Transaminase (ALT) >1.5 x Upper Level of Normal (ULN).
  • Bilirubin >1.5 x ULN
  • Creatinine clearance <30 mL/min
  • Clinically relevant anaemia at investigators discretion
  • Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant Pulmonary Hypertension (PH)
  • Cardiovascular diseases
  • More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
  • Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
  • International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
  • History of thrombo-embolic event within last year
  • Previous or planned hematopoietic stem cell transplantation
  • Clinical signs of malabsorption or needing parenteral nutrition
  • Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
  • Previous treatment with nintedanib or pirfenidone
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675581


Locations
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Belgium
UNIV UZ Gent
Gent, Belgium, 9000
France
HOP Avicenne
Bobigny, France, 93009
HOP Bichat
Paris, France, 75018
Germany
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GL
Portugal
Hospital Garcia de Orta, EPE
Almada, Portugal, 2801-951
Hospital Fernando Fonseca, EPE
Amadora, Portugal, 2720-276
Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08026
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03675581    
Other Study ID Numbers: 1199-0340
2018-001177-24 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Nintedanib
Ethinyl estradiol, levonorgestrel drug combination
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs