A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain

NCT05844995 | Completed Phase 1 FDA Drug

• 1 other identifier: CCSPAP005203
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (\<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to \<17 years of age with post-procedure orthodontic pain.

Conditions

Orthodontic Pain

Outcome Measures

Primary Outcomes (11)

• Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium

  CL/F is defined as apparent clearance of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Apparent Central Volume of Distribution (Vc/F) After Oral Dosing of Acetaminophen/Naproxen Sodium

  Vc/F is defined as apparent central volume of distribution after oral dosing of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Apparent Peripheral Volume of Distribution (Vp/F) After Oral Dosing of Acetaminophen/Naproxen Sodium

  Vp/F is defined as apparent peripheral volume of distribution after oral dosing of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Apparent Inter-compartmental Clearance (Q/F) of Acetaminophen/Naproxen Sodium

  Q/F is defined as apparent inter-compartmental clearance of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• First-order Absorption Rate Constant (Ka) of Acetaminophen/Naproxen Sodium

  Ka is defined as first-order absorption rate constant of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Maximum Plasma Concentration (Cmax) of Acetaminophen/Naproxen Sodium

  Cmax is defined as maximum plasma concentration of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Time of occurrence of Maximum Plasma Concentration (Tmax) of Acetaminophen/Naproxen Sodium

  Tmax is defined as time of occurrence of maximum plasma concentration of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Area Under the Plasma Concentration versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable Plasma Concentration (AUC[0-t])

  AUC(0-t) is defined as area under the plasma concentration versus time curve from start of drug administration until the time of the last measurable plasma concentration of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Area Under the Plasma Concentration versus Time Curve From Start of Drug Administration Until Infinity (AUC[0-infinite])

  AUC(0-infinite) is defined as area under the plasma concentration versus time curve from start of drug administration until infinity of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Terminal Elimination Rate Constant (lambda[z]) of Acetaminophen/Naproxen Sodium

  Lambda(z) is defined as terminal elimination rate constant of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

• Half Life (t1/2) of Acetaminophen/Naproxen Sodium

  T1/2 is defined as half life of acetaminophen/naproxen sodium.

  Pre-dose up to 48 hours post dose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  Up to 3 days

Study Arms (1)

Acetaminophen /Naproxen Sodium

EXPERIMENTAL

Participants with age group 12 to less than (\<) 17 years who undergone a non-surgical orthodontic procedure will enroll and receive fixed dose combination of acetaminophen/naproxen sodium tablet orally on baseline (Day 0).

Drug: Acetaminophen/Naproxen Sodium

Interventions

Acetaminophen/Naproxen Sodium DRUG

Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.

Acetaminophen /Naproxen Sodium

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A parent or a legal guardian of the participant has signed and dated the informed consent document and a written assent has been signed by the participant
• Has undergone an orthodontic procedure within 72 hours prior to dosing
• Is otherwise a healthy adolescent between the ages of 12 to less than (\<) 17 years at baseline (dosing). Health is defined as the absence of clinically relevant abnormalities as judged by the principle investigator (PI) on the basis of a detailed medical history, physical examination, blood pressure, respiratory rate and pulse rate measurements, and clinical laboratory tests. The responsible PI may request additional investigations or analyses if necessary
• Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
• Has been fasted for at least 10 hours prior to dose administration of the investigational product
• Is a non-tobacco user or previous user who completely stopped smoking or using any form of tobacco or nicotine-containing product \[including e-cigarettes, cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (such as dip, snuff, snus, and chewing tobacco)\] for at least 12 months before screening visit of this study
• If female, have a negative test for pregnancy at screening and baseline (dosing)
• Females of childbearing potential and males agree to the contraceptive requirements
• Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol
• Are willing for investigational product of this study to be the only analgesic product used during the study

You may not qualify if:

• Use of prescription or non-prescription medications within a period less than 5 half-lives before the first investigational product (IP) administration unless these are contraceptives or occasional use of other medications approved by the Investigator
• Use of Ibuprofen within 6 hours prior to the dose administration of the investigational product
• Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug
• Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatory drug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
• If female, has a positive pregnancy test or is breast-feeding or currently trying to become pregnant
• Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
• Has a positive test for drugs of abuse at screening or baseline (dosing)
• Has difficult venipuncture access and/or refuses to undergo venipuncture
• Has clinically significant renal or hepatic impairment according to the medically qualified Investigator discretion, or presence of a disease, which in the opinion of the Investigator, would preclude the use of IP
• Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease, or any other active inflammatory disease of the gastrointestinal tract such as ulcerative colitis or crohn's disease), or has a history of gastrointestinal surgery (including cholecystectomy) that would affect the pharmacokinetic (PK) assessment of the drug or the safety of the participant
• Has history of substance abuse, as judged by the PI, within 12 months preceding this study
• Has used alcohol within 24 hours of baseline visit and/or has positive alcohol test in expired air at screening or baseline visit
• Has used food or beverages containing xanthines (that is, tea, coffee, cola drinks, energy drinks or chocolate) for 48 hours prior to the dosing and during the study period
• Has used grapefruit and savoy oranges for 48 hours prior to the dosing and during the study period
• Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the dose of study drug

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

JBR Clinical Research LLP

Salt Lake City, Utah, 84107, United States

Location

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MeSH Terms

Interventions

Acetaminophen; Naproxen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: September 13, 2023
• Primary Completion: February 12, 2024
• Study Completion: February 14, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)