- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04933565
First in Human Study of ORG-129 in Healthy Volunteers
January 13, 2023 updated by: Origo Biopharma
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Bioavailability of ORG-129 After Single and Multiple Ascending Oral Doses (Including Food Interaction Effect) in Healthy Young Volunteers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08025
- Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
For the Multiple Dose Study, subjects should meet all the following inclusion criteria at screening visit:
- 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.
- Females must be of non-childbearing potential (i.e., surgically sterile) or have to use contraceptive measures (non-hormonal) such as condom, diaphragm or cervical/vault cap with spermicide 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 by obtains signed informed consent form approved by the CREC.
Exclusion Criteria:
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.
- 12 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.
- Clinically significant infections within 3 months or any infection within 28 days of screening.
- History or recurrent disseminated herpes simplex or herpes zoster.
- Personal or family history of hereditary immunodeficiency
- Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation.
- Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract
- Positive results of the drugs at screening period or the day before starting treatment period. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the PI).
- Females with positive results from the pregnancy test or breast-feeding (MAD).
- Females with hormonal contraceptive therapy.
- Positive Covid-19 diagnosis prior to hospital admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ORG-129
Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort
|
ORG-129 oral capsules
|
Placebo Comparator: Placebo
Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort
|
Placebo oral capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the safety and tolerability of SAD of ORG-129
Time Frame: day 1 through day 8
|
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
Time Frame: day 1 through day 12
|
by assessing the number, severity and type of treatment emergent adverse events
|
day 1 through day 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of ORG-129 when given as SAD: AUC
Time Frame: Day 1 and Day 2
|
Area under the plasma concentration-time curve (AUC)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: Cmax
Time Frame: Day 1 and Day 2
|
Maximum observed concentration (Cmax)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: Tmax
Time Frame: Day 1 and Day 2
|
Time to reach maximum observed concentration (Tmax)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: CL/F
Time Frame: Day 1 and Day 2
|
Oral Clearance (CL/F)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: Vz/F
Time Frame: Day 1 and Day 2
|
Terminal Phase Volume of Distribution(Vz/F)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: Kel
Time Frame: Day 1 and Day 2
|
Elimination Rate (Kel)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as SAD: t 1/2
Time Frame: Day 1 and Day 2
|
Elimination Halflife (t 1/2)
|
Day 1 and Day 2
|
Pharmacokinetics of ORG-129 when given as MAD: AUC
Time Frame: Day 1 and Day 5
|
Area under the plasma concentration-time curve (AUC)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: AUC
Time Frame: Day 1 and Day 10
|
Area under the plasma concentration-time curve (AUC)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: Cmax
Time Frame: Day 1 and Day 5
|
Maximum observed concentration (Cmax)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: Cmax
Time Frame: Day 1 and Day 10
|
Maximum observed concentration (Cmax)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: Tmax
Time Frame: Day 1 and Day 5
|
Time to reach maximum observed concentration (Tmax)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: Tmax
Time Frame: Day 1 and Day 10
|
Time to reach maximum observed concentration (Tmax)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: CL/F
Time Frame: Day 1 and Day 5
|
Oral Clearance (CL/F)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: CL/F
Time Frame: Day 1 and Day 10
|
Oral Clearance (CL/F)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: Vz/F
Time Frame: Day 1 and Day 5
|
Terminal Phase Volume of Distribution(Vz/F)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: Vz/F
Time Frame: Day 1 and Day 10
|
Terminal Phase Volume of Distribution(Vz/F)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: Kel
Time Frame: Day 1 and Day 5
|
Elimination Rate (Kel)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: Kel
Time Frame: Day 1 and Day 10
|
Elimination Rate (Kel)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: t 1/2
Time Frame: Day 1 and Day 5
|
Elimination Halflife (t 1/2)
|
Day 1 and Day 5
|
Pharmacokinetics of ORG-129 when given as MD: t 1/2
Time Frame: Day 1 and Day 10
|
Elimination Halflife (t 1/2)
|
Day 1 and Day 10
|
Pharmacokinetics of ORG-129 when given as MAD: Css
Time Frame: Day 5
|
concentration at steady state (Css)
|
Day 5
|
Pharmacokinetics of ORG-129 when given as MD: Css
Time Frame: Day 10
|
concentration at steady state (Css)
|
Day 10
|
PK of ORG-129 when given as MAD: C trough [ Time Frame: Day 2, 5 ]
Time Frame: Day 2 and Day 5
|
C trough
|
Day 2 and Day 5
|
PK of ORG-129 when given as MD: C trough [ Time Frame: Day 2, 10 ]
Time Frame: Day 2 and Day 10
|
C trough
|
Day 2 and Day 10
|
PD of ORG-129 when given as MD [ Time Frame: Day 2, 10 ]
Time Frame: Day 1-10
|
Biomarker analysis
|
Day 1-10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juan Martinez-Colomer, MD, Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
December 12, 2022
Study Completion (Actual)
January 9, 2023
Study Registration Dates
First Submitted
June 18, 2021
First Submitted That Met QC Criteria
June 18, 2021
First Posted (Actual)
June 21, 2021
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ORG129-CT01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States