A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects

NCT03363815 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-90001-CP-004U1111-1205-5329
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows:

• Screening (Days -21 through -2)
• Baseline phase for each study period (Periods 1 and 2)
• Treatment phase for each study period (Periods 1 and 2)
• Follow-up telephone call

Conditions

Heathy Volunteer

Keywords

Healthy Volunteer; CC-90001; Pharmacokinetics; Omeprazole; Midazolam; Warfarin; Rosuvastatin; Metformin; Digoxin; Nintedanib

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic- Cmax

  Maximum observed plasma concentration

  up to approximately 2.5 months

• Pharmacokinetic- AUC0-t

  AUC from time zero to the last quantifiable concentration

  up to approximately 2.5 months

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment until at least 28 days after completion of study treatment

Study Arms (4)

Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

EXPERIMENTAL

Patient will receive CC-90001, 20mg Omeprazole, 2mg Midazolam 10mg Warfarin and 10mg Vitamin K

Drug: CC-90001; Drug: Omeprazole; Drug: Midazolam; Drug: Warfarin; Dietary Supplement: Vitamin K

Part 2- Rosuvastatin and CC-90001

EXPERIMENTAL

Patients will receive CC-90001 and 10mg of Rosuvastatin

Drug: CC-90001; Drug: Rosuvastatin

Part 3: Metformin + Digoxin and CC-90001

EXPERIMENTAL

Patients will receive CC-90001, 500mg Metformin and 0.25mg, Digoxin

Drug: CC-90001; Drug: Metformin; Drug: Digoxin

Part 4: Nintedanib and CC-90001

EXPERIMENTAL

Patients will receive CC-90001 and 100mg of Nintedanib

Drug: CC-90001; Drug: Nintedanib

Interventions

CC-90001 DRUG

CC-90001

Part 2- Rosuvastatin and CC-90001; Part 3: Metformin + Digoxin and CC-90001; Part 4: Nintedanib and CC-90001; Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

Omeprazole DRUG

Omeprazole

Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

Midazolam DRUG

Midazolam

Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

Warfarin DRUG

Warfarin

Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

Vitamin K DIETARY_SUPPLEMENT

Vitamin K

Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001

Rosuvastatin DRUG

Rosuvastatin

Part 2- Rosuvastatin and CC-90001

Metformin DRUG

Metformin

Part 3: Metformin + Digoxin and CC-90001

Digoxin DRUG

Digoxin

Part 3: Metformin + Digoxin and CC-90001

Nintedanib DRUG

Nintedanib

Part 4: Nintedanib and CC-90001

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy all of the following criteria to be eligible for enrollment into the study:
• Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
• Must be able to communicate with the investigator and to understand and adhere to the study visit schedule and other protocol requirements.
• Must be a male or female of any race, aged ≥ 18 to ≤ 64 years of age (inclusive) at the time of signing the ICF.
• Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing during the course of the study and at the end of the study. This applies even if the subject practices true abstinence from heterosexual contact. Note: Females of childbearing potential are not permitted in Part 4.
• Part 4 only: Female subjects must be of nonchildbearing potential as confirmed by medical history. Females of childbearing potential are permitted in Parts 1, 2, and 3.
• Male subjects must practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis, as applicable) or agree to use a male condom (latex or nonlatex condom not made out of natural \[animal\] membrane \[eg, polyurethane\]) during sexual contact with a pregnant female or a FCBP while participating in the study and for at least 28 days after the last dose of study drug, even if he has undergone a successful vasectomy as confirmed by medical history.
• Must have a body mass index ≥ 18 and ≤ 33 kg/m2 (inclusive) at the time of signing the ICF.
• Must be healthy as determined by the investigator on the basis of medical history, clinical laboratory test results, vital signs, and 12-lead ECG at screening and Period 1 check-in, as applicable:
• Must be afebrile (febrile is defined as ≥ 38°C or 100.3°F).
• Systolic blood pressure must be in the range of 90 to 140 mmHg, diastolic blood pressure must be in the range of 55 to 90 mmHg, and pulse rate must be in the range of 50 to 110 bpm. Repeat vital signs may be measured at investigator discretion.
• Corrected QT interval using Fridericia's formula (QTcF) value must be ≤ 430 msec for male subjects and ≤ 450 msec for female subjects. An ECG may be repeated up to two times, and the average of the QTcF values will be used to determine subject eligibility.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment into the study:
• History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders as determined by the investigator.
• Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable).
• Use of any prescribed systemic or topical medication, including vaccines, within 30 days of the first dose administration.
• Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 14 days of the first dose administration.
• Use of any metabolic enzyme inhibitors or inducers that would affect the relevant drugs for that part of the study within 30 days of the first dose administration unless determined by the investigator that there will be no impact on the study integrity or subject safety. The Indiana University "P450 Drug Interaction Table" should be used to determine inhibitors and/or inducers of metabolic enzymes (http://medicine.iupui.edu/clinpharm/ddis/table/aspx).
• Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
• Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure). Appendectomy and cholecystectomy are acceptable.
• Donated blood or plasma within 8 weeks before the first dose administration.
• History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years before dosing or positive drug screening test reflecting consumption of illicit drugs.
• History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing or positive alcohol screen.
• Known to have serum hepatitis; known to be a carrier of the hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody (anti-HBc), or hepatitis C antibody (HCV Ab); have a positive result to the test for hepatitis B or hepatitis C virus at screening or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening. Subjects whose results are compatible with prior immunization against hepatitis B may be included at the discretion of the investigator.
• Use of tobacco- or nicotine-containing products within 3 months prior to Period 1 check in.
• History of multiple drug allergies (ie, 2 or more).
• Are allergic to or hypersensitive to any of the drugs used in the part of the study in which the subject will participate.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

CC-90001; Omeprazole; Midazolam; Warfarin; Vitamin K; Rosuvastatin Calcium; Metformin; Digoxin; nintedanib

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phytol; Diterpenes; Terpenes; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Pyrimidines; Biguanides; Guanidines; Amidines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Glycosides; Carbohydrates

Study Officials

• Francisco Ramirez-Valle, MD, PhD.

  Celgene

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: December 4, 2017
• Primary Completion: July 29, 2018
• Study Completion: July 29, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (1)