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AcromegalyPhase 1ONO-5788-02NCT03849872

Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788

A Phase 1 study testing ONO-5788 and [14C]-ONO-5788 in people with Acromegaly, run by Ono Pharmaceutical Co., Ltd. at 1 site in Netherlands.

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

A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1 to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as intravenous and oral forms; part 2 will assess the mass… Read more about this study

Who is it for?
Ages 21 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Acromegaly
What is being tested?
ONO-5788 and [14C]-ONO-5788
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
27 Feb 2019to 2 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 21 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The subject is willing and able to provide written informed consent.
  • Male subjects aged 21 to 65 inclusive at the time of signing the informed consent form.
  • The subject is able to communicate with the Investigator and the site staff.
  • A subject is eligible to participate if he is not trying to father a child, is willing to use one of the contraception methods listed in Section 5.3 and agrees not to donate sperm, from Day 1 of the study until 90 days after dosing.
  • The subject has a body mass index of 18.5 to 30.0 kg/m2, inclusive at screening.
  • The subject is healthy as determined by the Investigator (or medically qualified designee) based on the screening examinations including:
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  • Medical history
  • Physical examination
  • Vital signs
  • 12-lead ECG
  • Clinical laboratory tests
  • If any of the results of the above examinations are outside the locally-defined normal ranges, then the Investigator must consult with the Sponsor's Medical Officer prior to the subject being included in the study. Such subjects must only be included if the Investigator and Sponsor's Medical Officer believe the finding is unlikely to introduce additional risk for the subject if they enter the study.
  • The subject is a continuous non-smoker or has not used nicotine-containing products for at least 3 months prior to the first dose of study medication and will not use nicotine-containing products throughout the study, based on subject self-reporting.

Who cannot join

  • The Investigator deems the subject unsuitable for the study as a result of the screening examinations.
  • The subject is an employee of the Sponsor or contract research organization.
  • The subject has, or has a history of, any significant disease or disorder that would increase the risk for the subject if they were enrolled in the study or would affect study procedures or outcomes such as:
  • Gallstones, cholangitis, and/or cholecystitis;
  • Pancreatitis;
  • Hypothyroidism;
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  • Known diabetes mellitus type 1 or type 2;
  • Hypocalcaemia or hypokalaemia;
  • Hypoglycaemia or hyperglycaemia or fasting blood glucose outside normal local range;
  • Thrombocytopenia or other clinically significant haematologic abnormalities;
  • Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery (with the exception of appendectomy);
  • The subject has a positive, pre-study, hepatitis B, hepatitis C or human immunodeficiency virus test.
  • The subject has clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or admission, in the estimation and clinical judgment of the Investigator or designee.
  • The subject has a history of regular alcohol use, within the previous 12 months, of >21 units/week. A unit is defined as a half-pint (240 mL) of beer, a small glass (125 mL) of wine or a single measure (25 mL) of spirits.
  • The subject has a supine blood pressure less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg or a supine pulse rate lower than 50 beats per minute (bpm) or higher than 100 bpm at screening.
  • The subject has a history of regular use of drugs of abuse, including cannabinoids, cocaine, benzodiazepines, opioids, amphetamines, barbiturates, or methamphetamines within 1 year prior to first dose. Subjects who have been prescribed these drugs may be enrolled at the Investigator's discretion.
  • Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and (first) admission to the clinical research centre.
  • The subject has participated in a clinical trial within 3 months of dosing.
  • The subject has participated in more than 3 other drug studies in the 10 months prior to the first dose of study drug.
  • The subject has donated blood or had significant blood loss within 2 months prior to the first dose of study drug or has donated plasma within 7 days prior to the first dose of study drug.
  • The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of the first dose, unless in the opinion of the Investigator and Sponsor Medical Officer, the substance will not affect subject safety or interfere with the study procedures.
  • The subject has used any drugs known to be significant inducers or inhibitors of CYP enzymes and/or P-glycoprotein, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the Investigator or designee to confirm lack of interaction with study drugs.
  • The subject has a history of sensitivity to the study medication or the study medication class or any other drug.
  • The subject has an allergy that the Investigator or designee thinks may affect their safety during the study.
  • The subject is mentally or legally incapacitated.
  • The subject has been involved in a previous trial with ONO-5788.
  • The subject had a significant and/or acute illness within 5 days prior to dosing that, in the opinion of the Investigator, might impact safety assessments.
  • The subject has unsuitable veins for infusion or blood sampling.
  • The subject was exposed to radiation for diagnostic reasons (except dental xrays and plain xrays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.
  • The subject participated in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc. (add 1 year per 1 mSv).
  • Part 2 only: The subject has an irregular defecation pattern (less than once per 2 days or clinically abnormal number of stools per day).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA-EDS

    Groningen, NZ, 9728

Other trials in Netherlands

About this study

Official title: An Open-label, Single-dose Study to Evaluate the Excretion and Metabolism of Oral [14C]-ONO-5788 and Absolute Bioavailability of Oral ONO-5788 in Healthy Adult Male Subjects

A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1 to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as intravenous and oral forms; part 2 will assess the mass balance of ONO-5788 using orally administered radiolabelled ONO-5788

Conditions
Acromegaly
Being tested
ONO-5788, [14C]-ONO-5788
Medical subject headings
Acromegaly

What participants receive

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

  • ONO-5788Drug

    Investigational Drug

  • [14C]-ONO-5788Drug

    Investigational Drug

Study groups in NCT03849872
Study groupRoleWhat they receive
Part 1 Absolute BioavailabilityExperimentalSingle oral dose of 10 mg ONO-5788 capsule followed by iv infusion 100 μg/ 41 kBq (1.1 μCi) [14C]-ONO-5788 in 6 healthy male subjects.
Receives: Drug: ONO-5788; Drug: [14C]-ONO-5788
Part 2 Mass BalanceExperimentalSingle oral dose of 10 mg [14C]-ONO-5788 capsule containing 4.1 MBq (111 μCi) [14C]-radioactivity in 6 healthy male subjects.
Receives: Drug: [14C]-ONO-5788

What is being measured

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

  1. Absolute bioavailability of ONO-5788 in plasma

    Absolute bioavailability is calculated from the AUCs of iv and oral administration

    Measured: 72 hours

  2. Mass balance of ONO-5788

    Total recovery of radioactivity in urine and faeces following a single oral dose of [14C]-ONO-5788 (expressed as a percentage of the total radioactive dose administered)

    Measured: up to 42 days (until >90% of dose is recovered)

Secondary outcomes (12)

  1. Pharmacokinetics (AUC)

    Assessment of the plasma area under the curve of ONO-5788 and [14C]-ONO-5788

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  2. Pharmacokinetics (t1/2)

    Assessment of the total elimination half life of ONO-5788 and [14C]-ONO-5788

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  3. Pharmacokinetics (CL)

    Assessment of the clearance of ONO-5788 (Part 1 only)

    Measured: 24 hours through to 72 hours.

  4. Pharmacokinetics (CL/F)

    Assessment of Apparent oral clearance of ONO-5788

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  5. Pharmacokinetics (Vz)

    Assessment of Volume of distribution at terminal phase (Part 1 only)

    Measured: 24 hours through to 72 hours.

  6. Pharmacokinetics (Vz/F)

    Assessment of Apparent volume of distribution at terminal phase

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  7. Pharmacokinetics (CLr)

    Assessment of renal clearance (Part 2 only)

    Measured: Part 2: Day 1 to day 42 (depending on recovery of dose)

  8. Treatment emergent adverse events

    Number of participants with treatment emergent adverse events by severity

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  9. Clinical laboratory abnormalities

    Number of participants with abnormalities in clinical laboratory results

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  10. Changes in vital signs

    Number of participants with clinically significant changes in vital signs including pulse/heart rate, respiratory rate and blood pressure.

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  11. ECG abnormalities

    Number of participants with ECG abnormalities

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

  12. Physical examination assessment

    A complete physical examination consisting of all body systems (except for genitalia and anus/rectal examinations, which will only be performed if medically indicated). Number of participants with clinically significant changes will be reported

    Measured: Part 1: 24 hours through to 72 hours. Part 2: Day 1 to day 42 (depending on recovery of dose)

Timeline

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

  1. First posted21 Feb 2019
  2. Study start27 Feb 2019
  3. Primary completion2 Apr 2019
  4. Study completion2 Apr 2019

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03849872
Sponsor's protocol ID
ONO-5788-02
Acronym
ONO-5788-02
Status last verified
Nov 2019
First submitted
14 Feb 2019
Last updated
7 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONO-5788 and [14C]-ONO-5788 in people with Acromegaly, run by Ono Pharmaceutical Co., Ltd. at 1 site in Netherlands.

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 13 inclusion and 31 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 7 Nov 2019. 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 Netherlands. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Absolute bioavailability of ONO-5788 in plasma (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 NCT03849872.

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 7 Nov 2019.

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