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HealthyPhase 1NCT02209766

A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)

A Phase 1 study testing D5884 in people with Healthy, run by AstraZeneca at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects. Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
D5884
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteJapan
Study dates
Aug 2014to Nov 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male, 20 to 45 years of age (inclusive)
  • 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
  • Medically healthy with clinically insignificant screening results (eg, laboratory profile, medical history, ECGs, physical examination). Haemoglobin has to be ≥ the lower limit of the study site reference range, 12-lead ECG must have QT interval corrected for heart rate using Fridericia's formula(QTcF) >340 msec and <450 msec
  • No habitual use of drug(s) and non-tobacco/nicotine-containing products for a minimum of 6 months prior to dosing
  • Subjects must be willing and able to give written informed consent by signing an Institutional Review Board(IRB)-approved informed consent form (ICF) prior to admission to this study and follow the restrictions and procedures outlined for the study.
  • Mean fasting Triglyceride(TG) at -4 and -2 weeks of <150 mg/dL, and %TG change of <30% between Weeks -4 and -2

Who cannot join

  • Participation in another clinical study with an investigational product(IP) during the 4 months prior to enrolment
  • Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI
  • An individual who has abnormal laboratory values (ie, suggesting hepatic, renal, cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate current or past medical history for participation based on the decision of the principal investigator(PI)
  • A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
  • A positive urine drug/alcohol test at screening or admission (Visit 3, Day -1). (The drug test includes testing for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates and tricyclic anti-depressants. The alcohol test is an alcohol breath assessment.)
  • A positive test for syphilis, human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus antibodies.
Show all 18Show fewer
  • Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months of the planned time of admission
  • Current evidence, or a history of alcoholism or drug abuse within the 2 years prior to admission
  • A known sensitivity or allergy to soybeans, fish and/or shellfish
  • A hypersensitivity or idiosyncratic reaction to compounds related to EPA and/or DHA
  • Had used any prescription medication within 14 days prior to admission
  • Had used any over-the-counter (OTC) medication, including herbal products (bromelains, danshen, dong quai [Angelica sinensis], garlic, ginko biloba, ginseng, and St. John's wort), within the 7 days prior to admission
  • Had used any drugs known to significantly inhibit [strong or moderate] or induce liver enzymes involved in drug metabolism [cytochrome P450]) within 30 days prior to admission
  • Had donated blood or had had significant blood loss in excess of 200 mL within 1 month prior to admission or in excess of 400 mL within 3 months prior to admission
  • Had donated plasma within 7 days prior to admission
  • History of drug abuse or past history of alcohol abuse or habit of taking nicotine-containing product(s) on a daily basis
  • Those who have difficulty in giving blood during blood sampling via the peripheral vein
  • Any potential subjects who are considered as not eligible for the study in the opinion of the PI and/or the sub-investigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • CPC Clinical Trial Hospital

    Kagoshima, Kagoshima-ken, 8900081

Other trials in Japan

About this study

Official title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884

The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.

Read the detailed description

This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a single and multiple dose open-label study.

Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2 cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.

Following a screening period of a maximum of 42 days, subjects will reside at the study facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose administration in all 3 study arms will be done in the following sequence: a single dose of D5884 or placebo will be administered; this will be followed by a 2-day washout period; after the washout period, multiple doses of D5884 or placebo will be administered, once daily for 14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd cohort (Study Arm C) will receive 4 g D5884 (n=6).

The PK analysis included all evaluable PK data appropriate for the evaluation of interest (eg, with no major protocol deviations or violations thought to significantly affect the PK of the drug) from all subjects who received D5884.

Conditions
Healthy
Being tested
D5884, Placebo
Keywords
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, D5884, Japanese, Caucasian

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D5884Drug

    1st 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

  • PlaceboDrug

    1. st cohort: Dose 1(2g) D5884(n=3) in Japanese
    2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese
Study groups in NCT02209766
Study groupRoleWhat they receive
D5884ExperimentalD5884 capsule, Per oral(po)
Receives: Drug: D5884
PlaceboPlacebo comparatorPlacebo capsule, po
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)

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

    Measured: from first dosing (Day1) until follow-up (Day25)

Secondary outcomes (12)

  1. Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  2. Tmax in Plasma Baseline-adjusted Total EPA, Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  3. Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  4. Tmax in Plasma Baseline-adjusted Total DHA, Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  5. Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  6. Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  7. Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  8. Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  9. AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  10. AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  11. AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

  12. AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose

    Measured: Day1-3, 4, 7, 11, 14, 17-18 and 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209766
Sponsor's protocol ID
D5881C00005
Status last verified
Apr 2016
First submitted
1 Aug 2014
Last updated
17 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing D5884 in people with Healthy, run by AstraZeneca at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set) (time frame: from first dosing (Day1) until follow-up (Day25)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02209766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.

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