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Trial record 17 of 17 for:    acute porphyria | "Acute intermittent porphyria"

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

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ClinicalTrials.gov Identifier: NCT02943213
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : October 13, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Cycle Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
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
Adjunct in the Treatment of Tetanus
Control Manifestations of the Manic Type of Mani-depressive Illness
Relief of Intractable Hiccups
Intervention Drug: Chlorpromazine Hydrochloride
Enrollment 20
Recruitment Details  
Pre-assignment Details Study volunteers each received a single dose of 25 mg Chlorpromazine Hydrochloride Tablet in both treatment periods.
Arm/Group Title Chlorpromazine 25 mg
Hide Arm/Group Description

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Period Title: Treatment Period 1
Started 20
Completed 20
Not Completed 0
Period Title: Treatment Period 2
Started 20
Completed 20
Not Completed 0
Arm/Group Title Chlorpromazine 25 mg
Hide Arm/Group Description

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Caucasian
4
  20.0%
Black
16
  80.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
South Africa Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
2671
(94.5%)
2720
(69.6%)
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
1539
(57.6%)
1583
(48.9%)
3.Primary Outcome
Title 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
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
18670
(91.9%)
18470
(98.0%)
4.Primary Outcome
Title 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
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
13280
(58.4%)
13190
(61.6%)
5.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
15790
(74.9%)
19650
(106.2%)
6.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine
Hide Description Time Frame = sampling times.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
14460
(55.2%)
13740
(60.7%)
7.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: hr
1.33
(1 to 2)
1.33
(1 to 5)
8.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: hr
2.00
(1.33 to 3.00)
1.83
(1.00 to 3.00)
9.Secondary Outcome
Title Terminal Elimination Rate Constant (λz) - Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hr
0.05060
(17.9%)
0.04117
(32.6%)
10.Secondary Outcome
Title Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hr
0.07153
(19.5%)
0.07025
(19.8%)
11.Secondary Outcome
Title Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
13.70
(17.7%)
16.84
(40.7%)
12.Secondary Outcome
Title Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine
Hide Description Time Frame = sampling times
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description:

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
9.690
(31.8%)
9.867
(28.1%)
Time Frame From first visit first dose until post-study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Period 1 Treatment Period 2
Hide Arm/Group Description

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc

All-Cause Mortality
Treatment Period 1 Treatment Period 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1 Treatment Period 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Period 1 Treatment Period 2
Affected / at Risk (%) Affected / at Risk (%)
Total   2/20 (10.00%)   1/20 (5.00%) 
Cardiac disorders     
Tachycardia  1  0/20 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Soft Tissue Injury Right Side of Body * 2  1/20 (5.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia Left Index Finger  1  1/20 (5.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V19.0
2
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: James Price
Organization: Cycle Pharmaceuticals Ltd
Phone: +44 1223 803638
Responsible Party: Cycle Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02943213     History of Changes
Other Study ID Numbers: CT-004
PXL231486 ( Other Identifier: PAREXEL (Clinical Trial Unit) )
First Submitted: October 21, 2016
First Posted: October 24, 2016
Results First Submitted: May 22, 2017
Results First Posted: October 13, 2017
Last Update Posted: November 14, 2017