Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

NCT03864042 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: ARRAY-818-103C42210032019-001036-66
• Study Type: interventional
• Target: 56
• Locations: 5 countries
• Sites: 29

Brief Summary

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

Conditions

Advanced Solid Tumors; Metastatic Melanoma

Keywords

solid tumor; melanoma

Outcome Measures

Primary Outcomes (32)

• Maximum Concentration (Cmax) of Plasma Midazolam on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Total 1-OH Midazolam on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Free 1-OH Midazolam on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Glucuronide Conjugated 1-Hydroxymidazolam on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Absolute Caffeine on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Baseline-Adjusted Caffeine on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Paraxanthine on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Paraxanthine was the metabolite of caffeine.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Omeprazole on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma 5-OH Omeprazole on Day -7, Day 1, and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. 5-OH Omeprazole was the metabolite of omeprazole.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Rosuvastatin on Day -7, Day 1 and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Bupropion on Day -7, Day 1 and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Cmax of Plasma Hydroxybupropion on Day -7, Day 1 and Day 14

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Hydroxybupropion was the metabolite of bupropion.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Area Under the Concentration-Time Profile From Time 0 to The Time of The Last Quantifiable Concentration (AUClast) of Plasma Midazolam on Day -7, Day 1, and Day 14

  AUClast is area under the concentration-time profile (AUC) from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Total 1-OH Midazolam on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Free 1-OH Midazolam on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Glucuronide Conjugated 1-Hydroxymidazolam on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Absolute Caffeine on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Baseline-Adjusted Caffeine on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Paraxanthine on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Paraxanthine was the metabolite of caffeine.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Omeprazole on Day -7, Day 1, and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma 5-OH Omeprazole in Arm 1 on Day -7, Day 1 and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. 5-OH Omeprazole was the metabolite of omeprazole.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Rosuvastatin on Day -7, Day 1 and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Bupropion on Day -7, Day 1 and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• AUClast of Plasma Hydroxybupropion on Day -7, Day 1 and Day 14

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Hydroxybupropion was the metabolite of bupropion.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• The Amount Eliminated Via Urine Over an 8-Hour Period (Ae0-8) of Losartan on Day -7, Day 1 and Day 14

  Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours.

  0 to 8 hours after dosing on Days -7, 1 and 14

• Ae0-8 of E-3174 on Day -7, Day 1 and Day 14

  Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours. E-3174 was the metabolite of losartan.

  0 to 8 hours after dosing on Days -7, 1 and 14

• Ae0-8 of Dextromethorphan on Day -7, Day 1 and Day 14

  Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours.

  0 to 8 hours after dosing on Days -7, 1 and 14

• Ae0-8 of Dextrorphan on Day -7, Day 1 and Day 14

  Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours. Dextrorphan was the metabolite of dextromethorphan.

  0 to 8 hours after dosing on Days -7, 1 and 14

• Cmax of Plasma Encorafenib on Day 14 and Day 21 in Arm 3

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day 14 and Day 21

• Cmax of Plasma LHY746 on Day 14 and Day 21 in Arm 3

  Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. LHY746 was the metabolite of encorafenib.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day 14 and Day 21

• AUClast of Plasma Encorafenib on Day 14 and Day 21 in Arm 3

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day 14 and Day 21

• AUClast of Plasma LHY746 on Day 14 and Day 21 in Arm 3

  AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. LHY746 was the metabolite of encorafenib.

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day 14 and Day 21

Secondary Outcomes (117)

• Ratio of AUClast Values of the Metabolite Compared to Parent (MRAUClast) for 1-OH Midazolam/Midazolam on Day -7, Day 1 and Day 14

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• Ratio of AUC From Time Zero Extrapolated to Infinity (AUCinf) Values of the Metabolite Compared to Parent (MRAUCinf) for 1-OH Midazolam/Midazolam on Day -7, Day 1 and Day 14

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• MRAUClast for Paraxanthine/Caffeine on Day -7, Day 1 and Day 14

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• MRAUClast for 5-OH Omeprazole/Omeprazole on Day -7, Day 1 and Day 14

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

• MRAUCinf for 5-OH Omeprazole/Omeprazole on Day -7, Day 1 and Day 14

  Predose, and 1, 2, 3, 4, 6 and 8 hours postdose on Day -7, Day 1 and Day 14

Study Arms (3)

Arm 1 - CYP Probe Cocktail

EXPERIMENTAL

Patients will receive a single oral dose of the CYP Probe Cocktail on Day -7, Day 1, and Day 14: * 25 mg losartan oral tablet * 30 mg dextromethorphan oral capsule * 50 mg caffeine oral liquid * 20 mg omeprazole oral capsule * 2 mg midazolam oral syrup encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes.

Drug: losartan; Drug: dextromethorphan; Drug: caffeine; Drug: omeprazole; Drug: midazolam; Drug: encorafenib; Drug: binimetinib

Arm 2 - Rosuvastatin and Bupropion

EXPERIMENTAL

Patients will receive a single oral dose of rosuvastatin and bupropion once on Day -7, Day 1 and Day 14: * 10 mg rosuvastatin oral tablet * 75 mg bupropion immediate release (IR) oral tablet encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes.

Drug: rosuvastatin; Drug: bupropion immediate release (IR); Drug: encorafenib; Drug: binimetinib

Arm 3 - Modafinil

EXPERIMENTAL

Patients will begin encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) then receive continuous treatment of modafinil on Day 15 through Day 21: \- 400 mg modafinil tablet once daily (QD)

Drug: encorafenib; Drug: binimetinib; Drug: modafinil

Interventions

losartan DRUG

taken orally

Arm 1 - CYP Probe Cocktail

dextromethorphan DRUG

taken orally

Arm 1 - CYP Probe Cocktail

caffeine DRUG

taken orally

Arm 1 - CYP Probe Cocktail

omeprazole DRUG

taken orally

Arm 1 - CYP Probe Cocktail

midazolam DRUG

taken orally

Arm 1 - CYP Probe Cocktail

rosuvastatin DRUG

taken orally

Arm 2 - Rosuvastatin and Bupropion

bupropion immediate release (IR) DRUG

taken orally

Arm 2 - Rosuvastatin and Bupropion

encorafenib DRUG

taken orally

Arm 1 - CYP Probe Cocktail; Arm 2 - Rosuvastatin and Bupropion; Arm 3 - Modafinil

binimetinib DRUG

taken orally

Arm 1 - CYP Probe Cocktail; Arm 2 - Rosuvastatin and Bupropion; Arm 3 - Modafinil

modafinil DRUG

taken orally

Arm 3 - Modafinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or IV; or other BRAF V600-mutant advanced solid tumors
• Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to enrollment, as determined using a local test;
• Evidence of measurable or non-measurable lesions
• Patient with unresectable locally advanced or metastatic melanoma who has received no prior treatment or progressed on or after prior systemic therapy; Note: Prior therapy with a BRAF proto-oncogene serine-threonine protein kinase (BRAF) inhibitor and/or a mitogen-activated protein (MAP) kinase (MEK) inhibitor is permitted except in the regimen immediately prior to study entry
• Patient with other (non-melanoma) BRAF V600E and/or V600K -mutant advanced solid tumors who has progressed on standard therapy or for whom there are no available standard therapies; Note: Prior therapy with a BRAF inhibitor and/or a MEK inhibitor is permitted except in the regimen immediately prior to study entry
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Adequate bone marrow, hepatic and renal function as specified in the protocol
• ARM 1 ONLY: Non-smoker who has not used nicotine containing products for at least 3 months prior to the first dose.

You may not qualify if:

• Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable, with imaging (e.g., magnetic resonance imaging \[MRI\] or computed tomography \[CT\] demonstrating no current evidence of progressive brain metastases at screening);
• Symptomatic or untreated leptomeningeal disease;
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes);
• Clinically significant cardiac disease
• Known hyper-coagulability risks other than malignancy (e.g., Factor V Leiden syndrome);
• Thromboembolic event except catheter-related venous thrombosis ≤ 12 weeks prior to starting study treatment.
• Discontinuation of prior BRAF and/or MEK inhibitor treatment due to left ventricular dysfunction, pneumonitis/interstitial lung disease, or retinal vein occlusion;
• ARM 1 ONLY: Positive urine cotinine test at screening
• ARM 3 ONLY:
• History of psychosis, depression or mania;
• History of angioedema;
• History of mitral valve prolapse;
• History of left ventricular hypertrophy;

Sponsors & Collaborators

• Pfizer: lead
• Pierre Fabre Laboratories: collaborator

Study Sites (29)

UC Irvine Health

Orange, California, 92868-3201, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Hopkins Eye Clinic

Hopkins, Minnesota, 55343-8087, United States

Location

Park Nicollet Eye Clinic

Maple Grove, Minnesota, 55369, United States

Location

Regions Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

HealthPartners Specialty Center-Eye Care

Saint Paul, Minnesota, 55130, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

University of TN Medical Center

Knoxville, Tennessee, 37920, United States

Location

Mary Crowley Cancer Research - Medical City Hospital

Dallas, Texas, 75230, United States

Location

Utah Cancer Specialists

West Valley City, Utah, 84119, United States

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

Jewish General Hospital

Montrea, Quebec, H3T 1E2, Canada

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Beata Maria Ana

Madrid, 28007, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Clinica Rementeria

Madrid, 28010, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

Location

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, 28050, Spain

Location

CERCO

Seville, 41009, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Related Publications (2)

• Piscitelli J, Reddy MB, Wollenberg L, Del Frari L, Gong J, Matschke K, Williams JH. Evaluation of the effect of modafinil on the pharmacokinetics of encorafenib and binimetinib in patients with BRAF V600-mutant advanced solid tumors. Cancer Chemother Pharmacol. 2024 Sep;94(3):337-347. doi: 10.1007/s00280-024-04676-2. Epub 2024 Jun 15.

  PMID: 38878209 DERIVED

• Piscitelli J, Reddy MB, Wollenberg L, Del Frari L, Gong J, Wood L, Zhang Y, Matschke K, Williams JH. Clinical Evaluation of the Effect of Encorafenib on Bupropion, Rosuvastatin, and Coproporphyrin I and Considerations for Statin Coadministration. Clin Pharmacokinet. 2024 Apr;63(4):483-496. doi: 10.1007/s40262-024-01352-9. Epub 2024 Feb 29.

  PMID: 38424308 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Melanoma

Interventions

Losartan; Dextromethorphan; Caffeine; Omeprazole; Midazolam; Rosuvastatin Calcium; Bupropion; encorafenib; binimetinib; Modafinil

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Benzodiazepines; Benzazepines; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Pyrimidines; Propiophenones; Ketones; Benzhydryl Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 6, 2019
• Study Start: January 2, 2018
• Primary Completion: July 11, 2022
• Study Completion: May 29, 2023
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); CA (5); BE (1); US (11); NL (2)