First in Human Study of ORG-129 in Healthy Volunteers

NCT04933565 | Completed Phase 1

• 1 other identifier: ORG129-CT01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is performed to characterize the safety, tolerability and pharmacokinetics of ORG-129 after oral intake in healthy male and female volunteers after single ascending and multiple ascending doses.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• To assess the safety and tolerability of SAD of ORG-129

  by assessing the number, severity and type of treatment emergent adverse events

  day 1 through day 8

• To assess the safety and tolerability of MAD of ORG-129

  by assessing the number, severity and type of treatment emergent adverse events

  day 1 through day 12

Secondary Outcomes (26)

• Pharmacokinetics of ORG-129 when given as SAD: AUC

  Day 1 and Day 2

• Pharmacokinetics of ORG-129 when given as SAD: Cmax

  Day 1 and Day 2

• Pharmacokinetics of ORG-129 when given as SAD: Tmax

  Day 1 and Day 2

• Pharmacokinetics of ORG-129 when given as SAD: CL/F

  Day 1 and Day 2

• Pharmacokinetics of ORG-129 when given as SAD: Vz/F

  Day 1 and Day 2

Study Arms (2)

ORG-129

EXPERIMENTAL

Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort

Drug: ORG-129

Placebo

PLACEBO COMPARATOR

Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort

Drug: Placebo

Interventions

ORG-129 DRUG

ORG-129 oral capsules

ORG-129

Placebo DRUG

Placebo oral capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be included in the Single Dose Study, subjects should meet all the following criteria at the screening visit:
• Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
• Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
• Normal clinical records and physical examination.
• Laboratory tests (hematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
• Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50- 100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
• Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
• To be able to understand the nature of the study and comply with all their requirements.
• Free acceptance to participate in the study should be stated in an informed consent document signed by the volunteer which must be approved by the CREC.
• Healthy male/female subjects, 18-45 years (inclusive) of age at the time of enrolment.
• Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
• Normal clinical records and physical examination at screening and baseline.
• Laboratory tests (hematology, biochemistry and urianalysis) within the range of normal values, according to the laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
• Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50- 100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
• Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.

You may not qualify if:

• For the single dose study and multiple dose study meeting any of the following criteria at screening visit will be excluded from entry into the study:
• History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol \> 40 gr/day for men and \>24 for women (in MAD).
• Heavy consumer of stimulating beverages (\>5 coffees, teas, chocolate or cola drinks per day) and grape juice.
• Background of idiosyncrasy, food intolerance, hypersensitivity or adverse reactions to any drug or galenical form.
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
• Positive serology for hepatitis B, C or HIV.
• Background or clinically significant evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological disease or other chronic diseases.
• History of psychiatric diseases or epileptic seizures.
• lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
• Having undergone major surgery during the previous 6 months.
• Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
• Participation in other clinical trials during the previous 90 days (last drug to first drug administration period) in which an investigational drug or a commercially available drug was tested.
• Donation of blood during the 4 weeks preceding the drug administration.
• Severe or moderate acute illness 4 weeks before drug administration.

Sponsors & Collaborators

• Origo Biopharma: lead

Study Sites (1)

Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Study Officials

• Juan Martinez-Colomer, MD

  Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 21, 2021
• Study Start: June 1, 2021
• Primary Completion: December 12, 2022
• Study Completion: January 9, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)