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

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Brief Title

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

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

Brief 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 balance of ONO-5788 using orally
      administered radiolabelled ONO-5788
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Absolute bioavailability of ONO-5788 in plasma

Secondary Outcome

 Pharmacokinetics (AUC)

Condition

Acromegaly

Intervention

ONO-5788

Study Arms / Comparison Groups

 Part 1 Absolute Bioavailability
Description:  Single 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

February 27, 2019

Completion Date

April 2, 2019

Primary Completion Date

April 2, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. The subject is willing and able to provide written informed consent.

          2. Male subjects aged 21 to 65 inclusive at the time of signing the informed consent
             form.

          3. The subject is able to communicate with the Investigator and the site staff.

          4. 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.

          5. The subject has a body mass index of 18.5 to 30.0 kg/m2, inclusive at screening.

          6. The subject is healthy as determined by the Investigator (or medically qualified
             designee) based on the screening examinations including:

               -  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.

          7. 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.

        Exclusion Criteria:

          1. The Investigator deems the subject unsuitable for the study as a result of the
             screening examinations.

          2. The subject is an employee of the Sponsor or contract research organization.

          3. 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:

               1. Gallstones, cholangitis, and/or cholecystitis;

               2. Pancreatitis;

               3. Hypothyroidism;

               4. Known diabetes mellitus type 1 or type 2;

               5. Hypocalcaemia or hypokalaemia;

               6. Hypoglycaemia or hyperglycaemia or fasting blood glucose outside normal local
                  range;

               7. Thrombocytopenia or other clinically significant haematologic abnormalities;

               8. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery (with
                  the exception of appendectomy);

          4. The subject has a positive, pre-study, hepatitis B, hepatitis C or human
             immunodeficiency virus test.

          5. 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.

          6. 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.

          7. 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.

          8. 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.

          9. 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.

         10. The subject has participated in a clinical trial within 3 months of dosing.

         11. The subject has participated in more than 3 other drug studies in the 10 months prior
             to the first dose of study drug.

         12. 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.

         13. 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.

         14. 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.

         15. The subject has a history of sensitivity to the study medication or the study
             medication class or any other drug.

         16. The subject has an allergy that the Investigator or designee thinks may affect their
             safety during the study.

         17. The subject is mentally or legally incapacitated.

         18. The subject has been involved in a previous trial with ONO-5788.

         19. 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.

         20. The subject has unsuitable veins for infusion or blood sampling.

         21. 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.

         22. 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).

         23. Part 2 only: The subject has an irregular defecation pattern (less than once per 2
             days or clinically abnormal number of stools per day).
      

Gender

Male

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jan Jaap van Lier, MD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03849872

Organization ID

ONO-5788-02


Responsible Party

Sponsor

Study Sponsor

Ono Pharmaceutical Co. Ltd


Study Sponsor

Jan Jaap van Lier, MD, Principal Investigator, PRA-EDS


Verification Date

November 2019