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

NCT03849872 | Completed Phase 1 FDA Drug

• 1 other identifier: ONO-5788-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (2)

• Absolute bioavailability of ONO-5788 in plasma

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

  72 hours

• 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)

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

Secondary Outcomes (12)

• Pharmacokinetics (AUC)

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

• Pharmacokinetics (t1/2)

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

• Pharmacokinetics (CL)

  24 hours through to 72 hours.

• Pharmacokinetics (CL/F)

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

• Pharmacokinetics (Vz)

  24 hours through to 72 hours.

Study Arms (2)

Part 1 Absolute Bioavailability

EXPERIMENTAL

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.

Drug: ONO-5788; Drug: [14C]-ONO-5788

Part 2 Mass Balance

EXPERIMENTAL

Single oral dose of 10 mg \[14C\]-ONO-5788 capsule containing 4.1 MBq (111 μCi) \[14C\]-radioactivity in 6 healthy male subjects.

Drug: [14C]-ONO-5788

Interventions

ONO-5788 DRUG

Investigational Drug

Part 1 Absolute Bioavailability

[14C]-ONO-5788 DRUG

Investigational Drug

Part 1 Absolute Bioavailability; Part 2 Mass Balance

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Male subjects only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Medical history
• Physical examination
• Vital signs
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

PRA-EDS

Groningen, NZ, 9728, Netherlands

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Jan Jaap van Lier, MD

  PRA-EDS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 21, 2019
• Study Start: February 27, 2019
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

NL (1)