Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 "After Multiple Oral Doses" in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02907294
Recruitment Status : Terminated (change in the therapeutic indication)
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Palobiofarma SL

Brief Summary:
To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: PBF-999 / 160 mg Drug: PBF-999 / 320 mg Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 (160 mg and 320 mg) "After Multiple Oral Doses" in Healthy Volunteers
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PBF-999 Drug: PBF-999 / 160 mg
2 capsule 80 mg x 8 days

Drug: PBF-999 / 320 mg
4 capsule 80 mg x 8 days

Placebo Comparator: Placebo Drug: Placebo
2 capsules of placebo x 8 days 4 capsules of placebo x 8 days

Primary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: from day 0 to day 15 ]
    Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed

Secondary Outcome Measures :
  1. AUC [ Time Frame: from day 1 to 8 ]

    Day 1: baseline [pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+ 1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] post-medication;

    • Days 2 to 7: baseline [daily pre-dose] which corresponds at +24h of previous dose;
    • Day 8: baseline [daily pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] and [+ 24h] post-daily medication (D9).

  2. Cmax [ Time Frame: from day 1 to 8 ]
    Day 1: baseline [pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+ 1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] post-medication;

Other Outcome Measures:
  1. Leeds Sleep Evaluation Questionnaire [ Time Frame: from day 1 to 8 ]
  2. -Analogic visual scales (VAS/100) [ Time Frame: from day 1 to 8 ]
    ten scales will be used, Liking (only at +24 of the last drug administration), high, good effects, bad effects, sedation, nervous, euphoria, absent, vigouros and aphatetic.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or females subjects, 18-45 years (inclusive) of age at the time of enrollment.
  • 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. 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 use some contraceptive measures until 28 days post-administration.
  • Clinically acceptable blood pressure and pulse rate in supine and standing position. Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
  • Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2).
  • 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 Ethics Committee of the Hospital (CEIC).

Exclusion Criteria:

  • History of serious adverse reactions or hypersensitivity to any drug.
  • Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
  • Background or clinical evidence of chronic diseases.
  • Acute illness two weeks before drug administration.
  • Having undergone major surgery during the previous 6 months.
  • Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication
  • History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 g for men or 24 gr/day for women or high consumption of stimulating beverages (> 5 coffees, teas or coca cola drinks/ day)
  • Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
  • Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug.
  • Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.
  • Having donated blood during 4 weeks period before inclusion in the study.
  • 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.
  • 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradychardia (<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.
  • Symptoms of a significant somatic or mental illness in the four week period preceding drug administration.
  • History of hepatitis HBV and / or HCV and / or positive serology results which indicate the presence of hepatitis B surface antigen and / or detectable HCV ribonucleic acid (RNA).
  • Positive results from the HIV serology.
  • Females with positive results from the pregnancy test or breast-feeding
  • Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation.
  • Positive results of the drugs at screening period or the day before starting treatment period. A minimum list of drugs that will be screened for include Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the Principal Investigator).
  • Known hypersensitivity to the study drug or the composition of the galenical form
  • History of psychiatric diseases or epileptic seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02907294

CIM-Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Palobiofarma SL
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Joan Martinez, MD CIM-Sant Pau

Additional Information:
Responsible Party: Palobiofarma SL Identifier: NCT02907294     History of Changes
Other Study ID Numbers: IIBSP-PBF-2015-82
2015-004748-20 ( EudraCT Number )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Palobiofarma SL:
PDE10 inhibitor
phosphodiesterase 10 inhibitor
Huntington's disease
psychiatric disorders

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders