A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

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Brief Title

A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

Official Title

A Randomized, Double-blind, Placebo-Controlled, Four- Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-5788 in Healthy Adult Volunteers

Brief Summary

      This is a first in human study to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4
      parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a
      proof of principle part.
    

Detailed Description

      This single centre study will be comprised of 4 parts, Part A (SAD; up to 7 cohorts, 8
      subjects per cohort and including an assessment of food effect), a multiple-dose part (up to
      4 doses, 10 subjects per cohort); an elderly cohort (8 subjects per gender) and a proof of
      principle part.

      The single ascending dose part (Part A) comprises of increasing doses of an oral solution or
      capsule, with an investigation of the potential for food effects.

      The multiple ascending dose part (Part B, MAD; 14 days dosing) will be initiated after the PK
      and safety data are available from the single ascending dose part. Subjects in Part B will
      have ultrasound scans of the gallbladder during the study and at screening a HIDA scan will
      be performed. An evaluation of the PK in the elderly and any potential gender differences
      will also be evaluated in Part C. Subjects in Part C will have an ultrasound of the
      gallbladder at screening.

      Part D will be a proof of principle evaluation where the effects of ONO-5788 to inhibit the
      GHRH and arginine-stimulated GH release will be evaluated. Octreotide acetate is a reference
      arm in this part of the study.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of participants with treatment emergent adverse events by severity

Secondary Outcome

 Pharmacokinetics (AUC)

Condition

Acromegaly

Intervention

ONO-5788

Study Arms / Comparison Groups

 ONO-5788 Part A1
Description:  Single ascending doses of ONO-5788 or placebo in fasted healthy volunteers randomized 6 active : 2 placebo per group

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

76

Start Date

June 7, 2018

Completion Date

May 16, 2019

Primary Completion Date

May 16, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy, adult, male and female (women of non-child bearing potential, surgically
             sterile) volunteers, 18-55 years of age, inclusive, at screening (Parts A & B only).

          -  Healthy, adult, males and female (women of non-child bearing potential), ≥65 years of
             age at screening (Part C only).

          -  Healthy, adult, male, 18-40 years of age, inclusive, at screening (Part D only).

          -  Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs or ECG abnormalities (All Parts).

          -  Body mass index (BMI) of ≥18.5 to ≤30 kg/m2 at screening (Parts A, B & C).

          -  Body mass index (BMI) of ≥18.5 to <25 kg/m2 at screening (Part D only).

        Exclusion Criteria:

          -  History of any illness that, in the opinion of the PI or designee, might confound the
             results of the study or poses an additional risk to the subject by their participation
             in the study.

          -  History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          -  History or presence of hypersensitivity or idiosyncratic reaction to the study
             drugs,excipients or related compounds.

          -  History or presence of:

               1. Gallstones, cholangitis, and/or cholecystitis or clinically significant findings
                  on gallbladder ultrasound as determined by the Principal Investigator;

               2. Pancreatitis;

               3. Hypothyroidism;

               4. Known diabetes mellitus type 1 or type 2;

               5. Hypocalcaemia or hypokalemia;

               6. Hypoglycemia or hyperglycemia or fasting blood glucose outside normal local
                  range;

               7. Thrombocytopenia or other clinically significant hematologic abnormalities;

               8. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery;

               9. Known vitamin B12 deficiency.

              10. Abnormal gallbladder ejection fraction on hepatobiliary iminodiacetic acid (HIDA)
                  scan at screening (Part B only)

          -  Positive urine drug, alcohol or cotinine results at screening or check in.

          -  Clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate)
             abnormalities at screening or each check-in, in the estimation and clinical judgment
             of the PI or designee.

          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV).

          -  Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than
             140/90 mmHg (160/95 mmHg for Part C) at screening.

          -  Has engaged in strenuous physical exercise in the 48 hours prior first dosing or
             intends to undergo strenuous physical exercise at any time throughout the study.

          -  Donation of blood or significant blood loss within 56 days prior to the first dosing.

          -  Plasma donation within 7 days prior to the first dosing.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Terry O'Reilly, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03571594

Organization ID

ONO-5788-01


Responsible Party

Sponsor

Study Sponsor

Ono Pharmaceutical Co. Ltd


Study Sponsor

Terry O'Reilly, MD, Principal Investigator, Celerion


Verification Date

June 2019