Anti-PsychoticPhase 1NCT02943213

Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride

A Phase 1 study testing Chlorpromazine Hydrochloride in people with Anti-Psychotic and Management of Manifestations of Psychotic Disorders, run by Cycle Pharmaceuticals Ltd. at 1 site in South Africa.

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

Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia
What is being tested?: Chlorpromazine Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSouth Africa
Study dates: Nov 2016to Dec 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males and females, 18 to 65 years (both inclusive) at signing of informed consent.
Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
Body mass not less than 50 kg.
Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Non-smokers.
Females, if:

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Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
OR
Of childbearing potential, the following conditions are to be met:
Negative pregnancy test
If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.
Not lactating
Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study. Examples of reliable methods of contraception include non-hormonal intrauterine device, and barrier methods combined with an additional contraceptive method.
In this study the concomitant use of hormonal contraceptives is NOT allowed. Other methods, if considered by the investigator as reliable, will be accepted.
Written consent given for participation in the study.

Who cannot join

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females.
Consumption of more than 5 cups of coffee (or equivalent amounts of caffeine) per day.
Regular exposure to substances of abuse (other than alcohol) within the past year.
Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
In this study the concomitant use of hormonal contraceptives is NOT allowed.

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Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 10 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin), whichever is the longer) before administration of IMP in this study, at the discretion of the investigator.
Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
A major illness during the 3 months before commencement of the screening period.
History of hypersensitivity or allergy to the IMP or its excipients or any related medication including phenothiazines or other anti-psychotics or anti-emetics.
History of extrapyramidal symptoms.
History of liver or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy.
Familial history of deep vein thrombosis.
Hereditary problems of galactose intolerance, Lapp lactase deficiency.
History of QT prolongation or signs of QT prolongation on ECG.
History of bronchial asthma or any other bronchospastic disease.
History of convulsions.
History of porphyria.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
Diagnosis of hypotension made during the screening period.
Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
Positive testing for HIV and Hepatitis B and Hepatitis C.
Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the investigator.
Positive urine screen for tobacco use.
Female subjects that are pregnant (positive pregnancy test) or breastfeeding.
Difficulty in swallowing.
Any specific investigational product safety concern.
Vulnerable subjects, e.g., persons in detention.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Farmovs Parexel
Bloemfontein, Kampuslaan Suid, 9300

Other trials in South Africa

About this study

Official title: A Single Center, Single Dose, Open-Label, Two-Period Replicate Pilot Study to Investigate Intra-subject Variability in the Bioavailability of a Formulation Containing Chlorpromazine Hydrochloride (25 mg Sugar Coated Tablets) in at Least 16 Healthy Males and Females Under Fasting Conditions

Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.

The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.

Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve and a wide safety margin. This will then allow for the modification of bioequivalence acceptance criteria in future pivotal studies which will reduce the number of participants required whilst still maintaining assurance of safety and efficacy.

Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine; 7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%

Read the detailed description

This will be a single-dose, open-label, two-period replicate pilot study with orally administered chlorpromazine hydrochloride 25 mg (sugar coated tablets) conducted under fasting conditions in at least 16 healthy male and female subjects at a single study center.

Up to 20 eligible subjects will be enrolled in the study with 16 evaluable subjects to complete the study.

Analytes to be measured will be Chlorpromazine and 7-hydroxy-Chlorpromazine (free) as stipulated by FDA Guidance for assessment of bioequivalence for Chlorpromazine.

Conditions: Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting, Relief of Restlessness and Apprehension Before Surgery, Acute Intermittent Porphyria
Being tested: Chlorpromazine Hydrochloride
Keywords: Chlorpromazine, Hydrochloride, Chlorpromazine Hydrochloride, Bioavailability, Variability, Variable, Absorption, USL Pharma, USL, Healthy, South Africa, Cycle, Anti-Psychotic
Medical subject headings: Vomiting, Porphyria, Acute Intermittent

What participants receive

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

Chlorpromazine HydrochlorideDrug
Also called Trade name: Chlorpromazine Hydrochloride 25 mg Tablets, USP
Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Study groups in NCT02943213
Study group	Role	What they receive
Treatment Period 1	Experimental	First dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet. Receives: Drug: Chlorpromazine Hydrochloride
Treatment Period 2	Experimental	Second dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet. Receives: Drug: Chlorpromazine Hydrochloride

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times.
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours

Secondary outcomes (6)

Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Terminal Elimination Rate Constant (λz) - Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine
Time Frame = sampling times
Measured: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours

Timeline

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

Nov 2016Dec 2016

First posted24 Oct 2016 (estimated)
Study startNov 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anti-PsychoticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02943213
Sponsor's protocol ID: CT-004
Other IDs: PXL231486
Status last verified: Oct 2017
First submitted: 21 Oct 2016
Last updated: 14 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: participants are healthy volunteers.

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Single Dose, Open-Label, Two-Period Replicate Pilot Study to Investigate Intra-subject Variability in the Bioavailability of a Formulation Containing Chlorpromazine Hydrochloride (25 mg Sugar Coated Tablets) in at Least 16 Healthy Males and Females Under Fasting Conditions
ClinicalTrials.gov ID: NCT02943213
Acronym / sponsor ID: CT-004
Conditions: Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting, Relief of Restlessness and Apprehension Before Surgery, Acute Intermittent Porphyria
Keywords: Chlorpromazine, Hydrochloride, Chlorpromazine Hydrochloride, Bioavailability, Variability, Variable, Absorption, USL Pharma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Cycle Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Collaborators: Parexel
Study start: Nov 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 24 Oct 2016 (estimated)
Results: Posted 13 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.

The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.

Detailed description

Up to 20 eligible subjects will be enrolled in the study with 16 evaluable subjects to complete the study.

Analytes to be measured will be Chlorpromazine and 7-hydroxy-Chlorpromazine (free) as stipulated by FDA Guidance for assessment of bioequivalence for Chlorpromazine.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Period 1	Experimental	Drug: Chlorpromazine HydrochlorideFirst dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Treatment Period 2	Experimental	Drug: Chlorpromazine HydrochlorideSecond dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Healthy males and females, 18 to 65 years (both inclusive) at signing of informed consent.
Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
Body mass not less than 50 kg.
Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Non-smokers.

Key exclusion criteria (30 listed)

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females.
Consumption of more than 5 cups of coffee (or equivalent amounts of caffeine) per day.
Regular exposure to substances of abuse (other than alcohol) within the past year.
Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chlorpromazine HydrochlorideAlso: Trade name: Chlorpromazine Hydrochloride 25 mg Tablets, USPChlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.	Drug	Treatment Period 1, Treatment Period 2

Primary outcome

Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.
Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time Frame = sampling times.

6 secondary outcomes

Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Terminal Elimination Rate Constant (λz) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours
Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine
Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours

Results and safety

Results posted to the registry on 13 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chlorpromazine 25 mg	20	20

Primary outcome: Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine

Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Treatment Period 1 n = 20	Treatment Period 2 n = 20
Value	2671 (94.5)	2720 (69.6)

Population analysed: All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine

Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Treatment Period 1 n = 20	Treatment Period 2 n = 20
Value	1539 (57.6)	1583 (48.9)

Primary outcome: Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine

Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Treatment Period 1 n = 20	Treatment Period 2 n = 20
Value	18670 (91.9)	18470 (98.0)

Primary outcome: Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine

Time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Treatment Period 1 n = 20	Treatment Period 2 n = 20
Value	13280 (58.4)	13190 (61.6)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first visit first dose until post-study visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Period 1	0 of 20 (0%)	2 of 20 (10%)	Not reported
Treatment Period 2	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. participants are healthy volunteers.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Yolandi Swart, FCPHM(SA) principal investigator

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 30 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 14 Nov 2017. 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 South Africa. 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. 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?

Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine (time frame: 0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours). The study lists 6 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 NCT02943213.

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 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.