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D5884

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 17, 2016

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

D5884 · 1 trial · 1 indication

Phase 1 1
NCT02209766A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)Healthy
COMPLETED86 Analytics
PHASE1COMPLETED
A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
Healthy
NCT0220976686
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Study Endpoints

Primary Endpoints

Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)
from first dosing (Day1) until follow-up (Day25)

Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)

Secondary Endpoints

Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose
Day1-3, 4, 7, 11, 14, 17-18 and 25
Tmax in Plasma Baseline-adjusted Total EPA, Single Dose
Day1-3, 4, 7, 11, 14, 17-18 and 25
Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose
Day1-3, 4, 7, 11, 14, 17-18 and 25
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
D5884EXPERIMENTALD5884 capsule, Per oral(po)
PlaceboPLACEBO_COMPARATORPlacebo capsule, po

Interventions

NameTypeDescription
D5884DRUG1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian
PlaceboDRUG1. st cohort: Dose 1(2g) D5884(n=3) in Japanese 2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adult male, 20 to 45 years of age (inclusive) 2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2 for Caucasian subjects. BMI calculations to be conducted on height and weight values obtained at Visit 1 3. Medically healthy with cli...

Countries:Japan
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Frequently asked questions about D5884

What is D5884 used for?

D5884 is an investigational small molecule being studied in healthy volunteers. It was evaluated in a Phase 1 clinical trial to assess its effects after single and multiple doses. The study focused on healthy male Japanese and Caucasian participants. D5884 is not approved and remains in clinical development.

Who makes D5884?

D5884 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company conducted a Phase 1 clinical trial of D5884 in healthy volunteers to evaluate the drug's safety and tolerability.

What phase is D5884 in?

D5884 is in Phase 1 clinical development. A Phase 1 study of D5884 has been completed, involving healthy male participants. The drug is investigational and has not been approved for any use. Further clinical development would be required before any regulatory submission.

What clinical trials is D5884 in?

D5884 has one completed clinical trial, registered as NCT02209766. This Phase 1 study evaluated single and multiple doses of D5884 in healthy male Japanese and Caucasian participants. The trial enrolled 86 participants and was conducted in Japan. The study was placebo-controlled.

Is D5884 the same as Omega-3-carboxylic acids?

D5884 is also known as Omega-3-carboxylic acids, according to the clinical trial title. The Phase 1 study of D5884 was described as a study of D5884 (Omega-3-carboxylic acids) in healthy volunteers. This alternative name may be used in scientific literature and regulatory documents.