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Healthy VolunteersPhase 1NCT04933565

First in Human Study of ORG-129 in Healthy Volunteers

A Phase 1 study testing ORG-129 in people with Healthy Volunteers, run by Origo Biopharma at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
ORG-129
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteSpain
Study dates
1 Jun 2021to 9 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Barcelona, Catalonia, 08025

Other trials in Spain

About this study

Official title: 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.

Being tested
ORG-129, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORG-129Drug

    ORG-129 oral capsules

  • PlaceboDrug

    Placebo oral capsules

Study groups in NCT04933565
Study groupRoleWhat they receive
ORG-129ExperimentalSingle ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort
Receives: Drug: ORG-129
PlaceboPlacebo comparatorSingle ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the safety and tolerability of SAD of ORG-129

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

    Measured: day 1 through day 8

  2. To assess the safety and tolerability of MAD of ORG-129

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

    Measured: day 1 through day 12

Secondary outcomes (26)

  1. Pharmacokinetics of ORG-129 when given as SAD: AUC

    Area under the plasma concentration-time curve (AUC)

    Measured: Day 1 and Day 2

  2. Pharmacokinetics of ORG-129 when given as SAD: Cmax

    Maximum observed concentration (Cmax)

    Measured: Day 1 and Day 2

  3. Pharmacokinetics of ORG-129 when given as SAD: Tmax

    Time to reach maximum observed concentration (Tmax)

    Measured: Day 1 and Day 2

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

    Oral Clearance (CL/F)

    Measured: Day 1 and Day 2

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

    Terminal Phase Volume of Distribution(Vz/F)

    Measured: Day 1 and Day 2

  6. Pharmacokinetics of ORG-129 when given as SAD: Kel

    Elimination Rate (Kel)

    Measured: Day 1 and Day 2

  7. Pharmacokinetics of ORG-129 when given as SAD: t 1/2

    Elimination Halflife (t 1/2)

    Measured: Day 1 and Day 2

  8. Pharmacokinetics of ORG-129 when given as MAD: AUC

    Area under the plasma concentration-time curve (AUC)

    Measured: Day 1 and Day 5

  9. Pharmacokinetics of ORG-129 when given as MD: AUC

    Area under the plasma concentration-time curve (AUC)

    Measured: Day 1 and Day 10

  10. Pharmacokinetics of ORG-129 when given as MAD: Cmax

    Maximum observed concentration (Cmax)

    Measured: Day 1 and Day 5

  11. Pharmacokinetics of ORG-129 when given as MD: Cmax

    Maximum observed concentration (Cmax)

    Measured: Day 1 and Day 10

  12. Pharmacokinetics of ORG-129 when given as MAD: Tmax

    Time to reach maximum observed concentration (Tmax)

    Measured: Day 1 and Day 5

  13. Pharmacokinetics of ORG-129 when given as MD: Tmax

    Time to reach maximum observed concentration (Tmax)

    Measured: Day 1 and Day 10

  14. Pharmacokinetics of ORG-129 when given as MAD: CL/F

    Oral Clearance (CL/F)

    Measured: Day 1 and Day 5

  15. Pharmacokinetics of ORG-129 when given as MD: CL/F

    Oral Clearance (CL/F)

    Measured: Day 1 and Day 10

  16. Pharmacokinetics of ORG-129 when given as MAD: Vz/F

    Terminal Phase Volume of Distribution(Vz/F)

    Measured: Day 1 and Day 5

  17. Pharmacokinetics of ORG-129 when given as MD: Vz/F

    Terminal Phase Volume of Distribution(Vz/F)

    Measured: Day 1 and Day 10

  18. Pharmacokinetics of ORG-129 when given as MAD: Kel

    Elimination Rate (Kel)

    Measured: Day 1 and Day 5

  19. Pharmacokinetics of ORG-129 when given as MD: Kel

    Elimination Rate (Kel)

    Measured: Day 1 and Day 10

  20. Pharmacokinetics of ORG-129 when given as MAD: t 1/2

    Elimination Halflife (t 1/2)

    Measured: Day 1 and Day 5

  21. Pharmacokinetics of ORG-129 when given as MD: t 1/2

    Elimination Halflife (t 1/2)

    Measured: Day 1 and Day 10

  22. Pharmacokinetics of ORG-129 when given as MAD: Css

    concentration at steady state (Css)

    Measured: Day 5

  23. Pharmacokinetics of ORG-129 when given as MD: Css

    concentration at steady state (Css)

    Measured: Day 10

  24. PK of ORG-129 when given as MAD: C trough [ Time Frame: Day 2, 5 ]

    C trough

    Measured: Day 2 and Day 5

  25. PK of ORG-129 when given as MD: C trough [ Time Frame: Day 2, 10 ]

    C trough

    Measured: Day 2 and Day 10

  26. PD of ORG-129 when given as MD [ Time Frame: Day 2, 10 ]

    Biomarker analysis

    Measured: Day 1-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion12 Dec 2022
  4. Study completion9 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04933565
Sponsor's protocol ID
ORG129-CT01
Status last verified
Jan 2023
First submitted
18 Jun 2021
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ORG-129 in people with Healthy Volunteers, run by Origo Biopharma at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and tolerability of SAD of ORG-129 (time frame: day 1 through day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04933565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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