A Phase 1 Clinical Trial DHP2306R1 and DHP2306R2 in Healthy Adult Volunteers

NCT06395155 | Completed Phase 1

• 1 other identifier: 2306CS-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study is to evaluate the safety and pharmacokinetic drug interactions of DHP2306R1 and DHP2306R2 when administered alone and in combination in healthy conditions. Participants will be taken DHP2306R1 and DHP2306R2 alone or combination for 3 period, randomized in six-sequence.

Conditions

Musculoskeletal Pain

Keywords

Phase 1; DDI; rheumatoid arthritis; degenerative arthritis; acute pain

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss of DHP2306R1 and DHP2306R2

  Systemic exposure of DHP2302R1 and DHP2302R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

• Cmax of DHP2306R1 and DHP2306R2

  Plasma concentrations of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

Secondary Outcomes (6)

• AUC0-48 of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

• AUCinf of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

• Tmax of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

• t1/2 of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

• CL/F of DHP2306R1 and DHP2306R2

  At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period

Study Arms (6)

Sequence A

EXPERIMENTAL

DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day

Drug: DHP2306R1; Drug: DHP2306R2

Sequence B

EXPERIMENTAL

DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day

Drug: DHP2306R1; Drug: DHP2306R2

Sequence C

EXPERIMENTAL

DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day

Drug: DHP2306R1; Drug: DHP2306R2

Sequence D

EXPERIMENTAL

DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period

Drug: DHP2306R1; Drug: DHP2306R2

Sequence E

EXPERIMENTAL

DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period

Drug: DHP2306R1; Drug: DHP2306R2

Sequence F

EXPERIMENTAL

DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period ; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period

Drug: DHP2306R1; Drug: DHP2306R2

Interventions

DHP2306R1 DRUG

100mg per capsule, BID

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

DHP2306R2 DRUG

75mg per Tab, BID

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Healthy adult volunteers aged 19 years or older at the time of screening
• \) At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
• \) Those who do not have congenital or chronic diseases requiring treatment and no pathological symptoms or findings as a result of internal medical examination
• \) At the time of screening, those who were determined to be suitable subjects for clinical trials as a result of tests such as clinical laboratory tests, vital signs, physical examination (physical examination), and 12-lead electrocardiogram conducted according to the characteristics of the clinical trial drug.
• \) A person who, after receiving a detailed explanation of this clinical trial and fully understanding it, voluntarily decides to participate and agrees in writing to comply with the subject compliance requirements during the clinical trial period

You may not qualify if:

• \) Current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. Those who have
• ① Renal impairment
• ② Liver disorder
• \) For women, pregnant women (Urine-HCG positive) or lactating women
• \) Persons with a history of hypersensitivity or clinically significant hypersensitivity to DHP2306R1, DHP2306R2, or components of clinical investigational drugs, aspirin, non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), or sulfonamide drugs.
• \) People with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• \) Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs
• \) At the time of screening, those with clinically significant findings including the following findings on 12-lead electrocardiography
• QTc \> 450 ms for men, QTc \> 470 ms for women
• PR interval \> 200 ms
• QRS duration \> 120 ms
• \) At the time of screening, a person who shows the following results in clinical laboratory tests
• Those whose AST, ALT, ALP, γ-GT and Bilirubin total exceed twice the upper limit of the normal range in clinical laboratory tests to evaluate liver function
• If the blood creatinine level exceeds the reference range or the eGFR calculated by CKD-EPI is less than 60 mL/min/1.73m2
• Those whose CPK exceeds 2.5 times the upper limit of the normal range in clinical laboratory tests

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Jungbuk, South Korea

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Arthritis, Rheumatoid; Osteoarthritis; Acute Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Min Kyu Park

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized, Open-label, Multiple-dose, Six-sequence, Three-period, Three-treatment, Crossover

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: May 2, 2024
• Study Start: October 26, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: July 25, 2024

Record last verified: 2023-10

Locations

KR (1)