Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects

NCT03282838 | Completed Phase 1 FDA Drug

• 1 other identifier: DFN-15-CD-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• DFN-15 maximum plasma concentration (Cmax)

  Up to 72 hours

• DFN-15 area under the curve (AUC) 0-t

  Up to 72 hours

• DFN-15 area under the curve (AUC) 0-inf

  Up to 72 hours

Study Arms (3)

DFN-15 (fasted)

EXPERIMENTAL

Drug: DFN-15 (fasted)

DFN-15 (fed)

EXPERIMENTAL

Drug: DFN-15 (fed)

Comparator (fed)

EXPERIMENTAL

Drug: Comparator Celebrex® (fed)

Interventions

DFN-15 (fasted) DRUG

DFN-15 administered to fasted subjects

DFN-15 (fasted)

DFN-15 (fed) DRUG

DFN-15 administered to fed subjects

DFN-15 (fed)

Comparator Celebrex® (fed) DRUG

Comparator (Celebrex®) administered to fed subjects

Comparator (fed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male or female 19-55 years of age, inclusive, at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
• Females of childbearing potential: must either be sexually inactive (abstinent) for 30 days prior to the first dose and throughout the study or be using birth control method; Female subjects of non-childbearing potential and must have undergone sterilization procedures or be postmenopausal for at least 1 year prior
• Male subject must agree to use contraception or abstain during the study until 90 days beyond the last dose of study drug.
• Understands the study procedures in the informed consent form (ICF), and willing and able to comply with the protocol.

You may not qualify if:

• History or presence of hypersensitivity or idiosyncratic reaction to celecoxib, sulfonamides, aspirin or other NSAIDs or related compounds
• History or presence of clinically significant medical or psychiatric condition or disease
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
• liver enzyme tests greater than the upper limit of normal at screening
• Estimated creatinine clearance \<90 mL/minute at screening
• History or presence of alcoholism
• History or presence of bilateral pedal edema or generalized edema or fluid retention
• Female subjects who are pregnant or lactating or actively trying to conceive
• Positive urine drug or alcohol results at screening or check-in
• Positive cotinine at screening
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
• Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening
• Seated heart rate is lower than 45 bpm or higher than 100 bpm at screening
• Has been on a diet incompatible with the on-study diet
• Unable to refrain from or anticipates the use of prohibited medications

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: September 14, 2017
• Study Start: June 9, 2017
• Primary Completion: August 22, 2017
• Study Completion: January 12, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)